Diabetic Retinopathy, DRPhase 2NCT05296447
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
A Phase 2 study testing Aflibercept in people with Diabetic Retinopathy, DR, run by AbbVie at 20 sites in United States.
Trial summary
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy, DR
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 20 sitesUnited States
- Study dates
- 4 Apr 2022to Jun 2031
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must provide written, signed informed consent for this study
- Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study
- Must be willing and able to comply with all study procedures
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Southeast Retina Center, PC
Augusta, Georgia, 30909
Austin Clinical Research
Austin, Texas, 78750
California Retina Consultants
Bakersfield, California, 93309
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Duke University
Durham, North Carolina, 27705
Charles Retina Institute, P.C
Germantown, Tennessee, 38138
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Retinal Diagnostic Center
Los Angeles, California, 90017
Northern California Retina Vitreous Associates Medical Group Inc
Mountain View, California, 94040
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
California Eye Specialists Medical Group, Inc
Pasadena, California, 91107
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retinal Research Institute, LLC
Phoenix, Arizona, 85014
Retina Consultants San Diego
Poway, California, 92064
Sierra eye Associates
Reno, Nevada, 89502
California Retina Consultants CRC
Santa Barbara, California, 93103
New Jersey Retina
Teaneck, New Jersey, 07666
Retina Consultants of Texas
The Woodlands, Texas, 77384
About this study
Official title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
- Conditions
- Diabetic Retinopathy, DR
- Being tested
- Standard of Care, Aflibercept
- Keywords
- Diabetic Retinopathy, DR, Gene Therapy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareDrug
Standard of Care
AfliberceptDrug
Also called EYLEA
Injection
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Dose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration. Receives: Drug: Standard of Care |
| Supplemental Treatment | Other | DL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye. Receives: Drug: Standard of Care; Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
To evaluate the long-term safety of ABBV-RGX-314
Measured: 5 years inclusive of the parent study
Secondary outcomes (14)
Incidences of non-ocular AEs and any Adverse Events of Special Interest
Measured: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography
Measured: 5 years, inclusive of the parent study
Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Measured: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA
Measured: 5 years, inclusive to the parent study
Proportion of participants gaining or losing ≥ 5, 10, and 15 letters in BCVA compared with baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Measured: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT
Measured: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA
Measured: 5 years, inclusive to the parent study
Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)
Measured: 5 years, inclusive to the parent study
Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Measured: 5 years, inclusive to the parent study
Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Measured: 5 years, inclusive to the parent study
Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Measured: 5 years, inclusive to the parent study
Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Measured: 5 years, inclusive to the parent study
Proportion of participants with any sight-threatening ocular diabetic complications
Measured: 5 years, inclusive to the parent study
Mean number of retina specialist visits attended for complications of DR based on chart review
Measured: 5 years, inclusive to the parent study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start4 Apr 2022
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy, DRStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- REGENXBIO Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296447
- Sponsor's protocol ID
- RGX-314-5201 (M23-420)
- Other IDs
- M23-420
- Status last verified
- Nov 2026
- First submitted
- 16 Mar 2022
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05296447
- Acronym / sponsor ID
- RGX-314-5201 (M23-420)
- Conditions
- Diabetic Retinopathy, DR
- Keywords
- Diabetic Retinopathy, DR, Gene Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- REGENXBIO Inc.
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 25 Mar 2022 (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.
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Drug: Standard of CareDose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration. |
| Supplemental Treatment | Other | Drug: Standard of Care, Drug: AfliberceptDL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Must provide written, signed informed consent for this study
- Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study
- Must be willing and able to comply with all study procedures
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Standard of CareStandard of Care | Drug | Standard of Care, Supplemental Treatment |
| AfliberceptAlso: EYLEAInjection | Drug | Supplemental Treatment |
Primary outcome
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
Time frame: 5 years inclusive of the parent study
To evaluate the long-term safety of ABBV-RGX-314
14 secondary outcomes
Incidences of non-ocular AEs and any Adverse Events of Special Interest
Time frame: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography
Time frame: 5 years, inclusive of the parent study
Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Time frame: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA
Time frame: 5 years, inclusive to the parent study
Proportion of participants gaining or losing ≥ 5, 10, and 15 letters in BCVA compared with baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Time frame: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT
Time frame: 5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA
Time frame: 5 years, inclusive to the parent study
Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)
Time frame: 5 years, inclusive to the parent study
Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Time frame: 5 years, inclusive to the parent study
Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Time frame: 5 years, inclusive to the parent study
Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Time frame: 5 years, inclusive to the parent study
Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Time frame: 5 years, inclusive to the parent study
Proportion of participants with any sight-threatening ocular diabetic complications
Time frame: 5 years, inclusive to the parent study
Mean number of retina specialist visits attended for complications of DR based on chart review
Time frame: 5 years, inclusive to the parent study
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 6 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept in people with Diabetic Retinopathy, DR, run by AbbVie at 20 sites in United States.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) (time frame: 5 years inclusive of the parent study). 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 6 Nov 2026.