Diabetic RetinopathyPhase 2/3NAAVIGATENCT07592273
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
A Phase 2/3 study testing Surabgene Lomparvovec, Topical Steroid and Artificial Tears in people with Diabetic Retinopathy, run by AbbVie at 40 sites in 2 countries.
Trial summary
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Surabgene Lomparvovec, Topical Steroid and Artificial Tears
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- 40 sitesin 2 countries
- Study dates
- 1 Jun 2026to Jan 2036
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.
- Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1.
- Systemic
- Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)< 12% within 60 days prior to Screening Visit 1.
Who cannot join
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:
- Central retinal thickness (CRT) >= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).
- Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2
- Neovascularization from a cause other than DR, per investigator
- Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy
Show all 12Show fewer
- History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1
- Pregnant and breastfeeding individuals are excluded from this clinical study.
- Systemic
- Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1
- Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1
- Pregnant and breastfeeding individuals are excluded from this clinical study
Trial locations and contacts
40 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 2 countries
United States39 sites, 39 recruiting
- Recruiting
Southeast Retina Center /ID# 274739
Augusta, Georgia, 30909
- Recruiting
Austin Research Center for Retina /ID# 276101
Austin, Texas, 78705
- Recruiting
California Retina Consultants - Bakersfield /ID# 282990
Bakersfield, California, 93309
- Recruiting
Retina and Vitreous of Texas /ID# 283051
Bellaire, Texas, 77401
- Recruiting
Retina-Vitreous Associates Medical Group - Beverly Hills /ID# 282995
Beverly Hills, California, 90211
- Recruiting
Retina Center Of New Jersey /ID# 283088
Bloomfield, New Jersey, 07003
- Recruiting
Star Retina /ID# 276513
Burleson, Texas, 76028
- Recruiting
Retinal Diagnostic Center /ID# 275055
Campbell, California, 95008
- Recruiting
Charleston Neuroscience Institute - Charleston /ID# 275047
Charleston, South Carolina, 29414
- Recruiting
Illinois Retina Associates S.C /ID# 283048
Chicago, Illinois, 60657
- Recruiting
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas, 75231
- Recruiting
Southwest Retina Research Center /ID# 276094
Durango, Colorado, 81303
- Recruiting
The Retina Partners /ID# 274741
Encino, California, 91436
- Recruiting
Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
Hagerstown, Maryland, 21740
- Recruiting
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida, 33805
- Recruiting
Colorado Retina Associates /ID# 283006
Lakewood, Colorado, 80228
- Recruiting
University Retina - Lemont /ID# 283021
Lemont, Illinois, 60439
- Recruiting
Retina Associates - Lenexa /ID# 283004
Lenexa, Kansas, 66215
- Recruiting
Advanced Vision Surgery Center /ID# 275017
Longmont, Colorado, 80503
- Recruiting
Barnet Dulaney Perkins Eye Center - Mesa /ID# 283000
Mesa, Arizona, 85206
- Recruiting
Retina Associates Of Cleveland - Middleburg Heights Office /ID# 275985
Middleburg Heights, Ohio, 44130
- Recruiting
Northern California Retina Vitreous Associates /ID# 282994
Mountain View, California, 94040-4119
- Recruiting
Wagner Macula & Retina Center - Norfolk /ID# 275021
Norfolk, Virginia, 23502
- Recruiting
Florida Retina Institute - Orlando /ID# 283034
Orlando, Florida, 32806
- Recruiting
California Eye Specialists Medical Group /ID# 274705
Pasadena, California, 91107
- Recruiting
Retina Speciality Institute /ID# 274996
Pensacola, Florida, 32503
- Recruiting
Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
Phoenix, Arizona, 85053
- Recruiting
Maine Eye Center - Marginal Way Campus /ID# 275039
Portland, Maine, 04101
- Recruiting
Retina Northwest /ID# 283232
Portland, Oregon, 97221
Site Coordinator, 215-662-8675
- Recruiting
Retina Consultants San Diego /ID# 274748
Poway, California, 92064
- Recruiting
Sierra Eye Associates /ID# 274737
Reno, Nevada, 89502
- Recruiting
Retinal Consultants - Sacramento - Greenback Lane /ID# 283018
Sacramento, California, 95841
- Recruiting
Vistar Eye Center - Salem /ID# 282879
Salem, Virginia, 24153
- Recruiting
West Coast Retinal Medical Group /ID# 283007
San Francisco, California, 94109
- Recruiting
California Retina Consultants - Santa Barbara /ID# 283050
Santa Barbara, California, 93103
- Recruiting
Retina Macula Institute of Arizona /ID# 282881
Scottsdale, Arizona, 85255-4134
- Recruiting
Springfield Clinic - First /ID# 283028
Springfield, Illinois, 62702
- Recruiting
Macula Retina Vitreous Center - Torrance /ID# 282878
Torrance, California, 90503
- Recruiting
Bay Area Retina Associates /ID# 275032
Walnut Creek, California, 94598-5910
Puerto Rico1 site, 1 recruiting
- Recruiting
Emanuelli Research & Development Center /ID# 275378
Arecibo, 00612
About this study
Official title: An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).
This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.
Read more
In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Diabetic Retinopathy
- Being tested
- Surabgene Lomparvovec, Sham, Topical Steroid, Artificial Tears
- Keywords
- Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy, ABBV-RGX-314
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surabgene LomparvovecDrug
Solution Injection
ShamDrug
needleless injection without fluid
Topical SteroidDrug
Topical Drops
Artificial TearsDrug
Topical Drops
| Study group | Role | What they receive |
|---|---|---|
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A | Experimental | Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A. Receives: Drug: Surabgene Lomparvovec; Drug: Topical Steroid |
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B | Experimental | Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B. Receives: Drug: Surabgene Lomparvovec; Drug: Topical Steroid |
| Phase 2b: Sham + Artificial Tears -Regimen A | Placebo comparator | Participants will receive a single injection of sham+ artificial tears -Regimen A. Receives: Drug: Sham; Drug: Artificial Tears |
| Phase 2b: Sham + Artificial Tears -Regimen B | Placebo comparator | Participants will receive a single injection of Sham+ artificial tears -Regimen B. Receives: Drug: Sham; Drug: Artificial Tears |
| Phase 3: Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid Receives: Drug: Surabgene Lomparvovec; Drug: Topical Steroid |
| Phase 3: Sham + Artificial Tears | Placebo comparator | Participants will receive a single injection of Sham + artificial tears. Receives: Drug: Sham; Drug: Artificial Tears |
| Bilateral: B1-Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye. Receives: Drug: Surabgene Lomparvovec; Drug: Topical Steroid |
| Bilateral: B2-Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye. Receives: Drug: Surabgene Lomparvovec; Drug: Topical Steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)
Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Intraocular Inflammation
Percentage of participants who experience intraocular inflammation.
Measured: Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis
Percentage of participants who experience scleral inflammation including episcleritis.
Measured: Up to Approximately Week 104
Secondary outcomes (57)
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Participants will be assessed for the development of VTEs
Measured: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Participants will be assessed for the development of VTEs
Measured: Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Participants will be assessed for the progression to PDR or ASNV.
Measured: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Participants will be assessed for the progression to PDR or ASNV.
Measured: Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Participants will be assessed for the development of CI-DME.
Measured: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Participants will be assessed for the development of CI-DME.
Measured: Up to Approximately Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Percentage of participants who develop treatment-emergent ocular inflammation.
Measured: Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Percentage of participants who develop treatment-emergent ocular inflammation.
Measured: Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Percentage of participants who develop treatment-emergent ocular inflammation.
Measured: Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Percentage of participants who develop treatment-emergent ocular inflammation.
Measured: Up to approximately Week 52
Phase 2B: Percentage of Participants Achieving>= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Percentage of Participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 2B: Percentage of participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 2B: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Measured: Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Measured: Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Measured: Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Measured: Up to approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Percentage of participants who receive treatments for DR complications in the study eye.
Measured: Up to Approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Percentage of participants who receive treatments for DR complications in the study eye.
Measured: Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Participants will be assessed for the development of VTEs
Measured: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Participants will be assessed for the development of VTEs
Measured: Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Participants will be assessed for the progression to PDR or ASNV.
Measured: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Participants will be assessed for the progression to PDR or ASNV.
Measured: Up to Approximately Week104
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Participants will be assessed for the development of CI-DME.
Measured: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Participants will be assessed for the development of CI-DME.
Measured: Up to Approximately Week 104
Phase 3 (key secondary):Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 3: Percentage of Participants With No change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 3: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 52
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Measured: At Week 104
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Percentage of participants who receive treatments for DR complications in the study eye.
Measured: Up to approximately Week 52
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Percentage of participants who receive treatments for DR complications in the study eye.
Measured: Up to approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Serious Adverse Events (SAE)s
An SAE is defined as any AE, whether or not associated with study treatment that meets any of the following criteria: death of a participant, hospitalization or prolonged hospitalization, congenital anomaly, persistent or significant disability/incapacity, and important medical event requiring medical or surgical intervention to prevent serious outcome.
Measured: Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Vector Shedding in Urine
Vector shedding in urine is defined as measurement of vector Deoxyribonucleic Acid (DNA) concentrations in urine.
Measured: Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector Shedding in Tears
Vector shedding in tears is defined as measurement of vector DNA concentrations in tears.
Measured: Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector DNA Concentrations in Serum
Vector shedding in urine is defined as measurement of vector DNA concentrations in serum.
Measured: Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) Level
Change from baseline in DRSS level is defined as 0-step (no change), a ≥ 1-step, a ≥ 2-step, or a ≥ 3-step change.
Measured: Up to Approximately Week 104
Bilateral Portion: Maintenance of Visual Acuity From Baseline
Maintenance of visual acuity is defined as not losing 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline.
Measured: Up to Approximately Week 104
Bilateral portion: Change from baseline in serum anti-sura-vec Transgene product (TP) antibodies
Change from baseline in serum anti-sura-vec antibodies
Measured: Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Central Retinal Thickness (CRT) on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Change from baseline in CRT on SD-OCT.
Measured: Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Aqueous Humor Surabgene Lomparvovec (Sura-vec) Transgene product (TP) Concentration
Change from baseline in aqueous humor sura-vec TP concentration.
Measured: Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Serum Sura-vec Transgene product (TP) concentration
Change from baseline in serum sura-vec TP concentration.
Measured: Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Anti- Associated Virus Serotype 8 (AAV8) Transgene product (TP) antibodies
Change from baseline in serum anti-AAV8 TP antibodies.
Measured: Up to Approximately Week 104
Bilateral Portion: Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Participants will be assessed for the development of VTEs
Measured: Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Enzyme-linked ImmunoSpot (ELISpot to capsid or transgene)
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
Measured: Up to Approximately Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592273
- Sponsor's protocol ID
- M23-415
- Acronym
- NAAVIGATE
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)
- ClinicalTrials.gov ID
- NCT07592273
- Acronym / sponsor ID
- NAAVIGATE / M23-415
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy, ABBV-RGX-314
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).
This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.
In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A | Experimental | Drug: Surabgene Lomparvovec, Drug: Topical SteroidParticipants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A. |
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B | Experimental | Drug: Surabgene Lomparvovec, Drug: Topical SteroidParticipants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B. |
| Phase 2b: Sham + Artificial Tears -Regimen A | Placebo comparator | Drug: Sham, Drug: Artificial TearsParticipants will receive a single injection of sham+ artificial tears -Regimen A. |
| Phase 2b: Sham + Artificial Tears -Regimen B | Placebo comparator | Drug: Sham, Drug: Artificial TearsParticipants will receive a single injection of Sham+ artificial tears -Regimen B. |
| Phase 3: Surabgene Lomparvovec + Steroid | Experimental | Drug: Surabgene Lomparvovec, Drug: Topical SteroidParticipants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid |
| Phase 3: Sham + Artificial Tears | Placebo comparator | Drug: Sham, Drug: Artificial TearsParticipants will receive a single injection of Sham + artificial tears. |
| Bilateral: B1-Surabgene Lomparvovec + Steroid | Experimental | Drug: Surabgene Lomparvovec, Drug: Topical SteroidParticipants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye. |
| Bilateral: B2-Surabgene Lomparvovec + Steroid | Experimental | Drug: Surabgene Lomparvovec, Drug: Topical SteroidParticipants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.
- Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1.
- Systemic
- Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)< 12% within 60 days prior to Screening Visit 1.
Key exclusion criteria (12 listed)
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:
- Central retinal thickness (CRT) >= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).
- Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2
- Neovascularization from a cause other than DR, per investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surabgene LomparvovecSolution Injection | Drug | Bilateral: B1-Surabgene Lomparvovec + Steroid, Bilateral: B2-Surabgene Lomparvovec + Steroid, Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A, Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B, Phase 3: Surabgene Lomparvovec + Steroid |
| Shamneedleless injection without fluid | Drug | Phase 2b: Sham + Artificial Tears -Regimen A, Phase 2b: Sham + Artificial Tears -Regimen B, Phase 3: Sham + Artificial Tears |
| Topical SteroidTopical Drops | Drug | Bilateral: B1-Surabgene Lomparvovec + Steroid, Bilateral: B2-Surabgene Lomparvovec + Steroid, Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A, Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B, Phase 3: Surabgene Lomparvovec + Steroid |
| Artificial TearsTopical Drops | Drug | Phase 2b: Sham + Artificial Tears -Regimen A, Phase 2b: Sham + Artificial Tears -Regimen B, Phase 3: Sham + Artificial Tears |
Primary outcome
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)
Time frame: Up to Approximately Week 104
Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Bilateral Portion: Participants Who Experience Intraocular Inflammation
Time frame: Up to Approximately Week 104
Percentage of participants who experience intraocular inflammation.
Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis
Time frame: Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
57 secondary outcomes
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Time frame: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Time frame: Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Time frame: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Time frame: Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Time frame: Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Time frame: Up to Approximately Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Time frame: Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Time frame: Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Time frame: Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
Time frame: Up to approximately Week 52
Phase 2B: Percentage of Participants Achieving>= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 2B: Percentage of Participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Phase 2B: Percentage of participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
Time frame: At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
Time frame: At Week 104
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 2B: Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Phase 2B: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Time frame: Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Time frame: Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Time frame: Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
Time frame: Up to approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Time frame: Up to Approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
Time frame: Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Time frame: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Time frame: Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Time frame: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
Time frame: Up to Approximately Week104
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Time frame: Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
Time frame: Up to Approximately Week 104
Phase 3 (key secondary):Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 3: Percentage of Participants With No change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Phase 3: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
Time frame: At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
Time frame: At Week 104
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Time frame: At Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surabgene Lomparvovec, Topical Steroid and Artificial Tears in people with Diabetic Retinopathy, run by AbbVie at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye (time frame: At Week 52). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.