Diabetic Retinal DiseasePhase 4ASNCT07567833
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
A Phase 4 study testing Anti-Vascular Endothelial Growth Factor in people with Diabetic Retinal Disease, run by Jaeb Center for Health Research at 8 sites in United States.
Trial summary
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinal Disease
- What is being tested?
- Anti-Vascular Endothelial Growth Factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Jul 2026to Dec 2027
- Phase
- Phase 4
- 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
- Age ≥18 years
- Diagnosed with Type 1 or Type 2 diabetes
- Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
- At least 1 eye with CI-DME requiring treatment
- Able and willing to provide informed consent.
Who cannot join
- Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
- Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Southeast Retina Center, P.C.
Augusta, Georgia, 30909
Dennis M Marcus, MD, 709-650-0061, amitchell@southeastretina.com
- Recruiting
Retina Consultants of Texas
Beaumont, Texas, 77707
William Pearce, MD, 9008335921, alaida.jimenez@retinaconsultantstexas.com
- Recruiting
Boston Medical Center Corporation
Boston, Massachusetts, 02118
Steven D Ness, MD, 617-414-4020, sreevardhan.alluri@bmc.org
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Paul A Edwards, MD, 313-874-9167, mdakhil1@hfhs.org
- Recruiting
Retina Consultants of Southern California
Huntington Beach, California, 92647
Hani Salehi-Had, MD, 657-227-9496, i.gomez@retinasocal.com
- Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
Shripaad Y Shukla, MD, 412-683-5300, merlottil@retinapittsburgh.com
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Andrew J. Barkmeier, MD, 507-538-8119, Taylor.Laura2@mayo.edu
- Recruiting
Pittsburgh Clinical Trial Consortium
Sewickley, Pennsylvania, 15143
Leanne T. Labriola, DO, MBA, 412-301-5326, franco@pghtrials.com
About this study
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
- Conditions
- Diabetic Retinal Disease
- Being tested
- Anti-Vascular Endothelial Growth Factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Vascular Endothelial Growth FactorDrug
Also called Anti-VEGF
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
| Study group | Role | What they receive |
|---|---|---|
| Mild center-involved diabetic macular edema | Active comparator | Eyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men Receives: Drug: Anti-Vascular Endothelial Growth Factor |
| Moderate Center-involved diabetic macular edema | Active comparator | Eyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men Receives: Drug: Anti-Vascular Endothelial Growth Factor |
| Severe Center-involved diabetic macular edema | Active comparator | Severe CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men Receives: Drug: Anti-Vascular Endothelial Growth Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Measured: Baseline to 1 year
Change in area under the log contrast sensitivity function (AULCSF)
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Measured: Baseline to 1 year
Change in electroretinography parameter
Measured by the RETeval device
Measured: Baseline to 1 year
Change in reading performance
Measured by the MNREAD test
Measured: Baseline to 1 year
Change in visual field function
Measured by Humphrey Visual Field testing
Measured: Baseline to 1 year
Change in diabetic retinopathy severity
Assessed by ultra-widefield (UWF) color fundus photography
Measured: Baseline to 1 year
Change in retinal vascular pathology
Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Measured: Baseline to 1 year
Change in retinal structure
measured by optical coherence tomography (OCT)
Measured: Baseline to 1 year
Change in retinal microvascular parameter
Measured by optical coherence tomography angiography (OCTA)
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start31 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinal DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567833
- Sponsor's protocol ID
- Protocol AS (1)
- Other IDs
- UG1EY014231
- Acronym
- AS
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
- ClinicalTrials.gov ID
- NCT07567833
- Acronym / sponsor ID
- AS / Protocol AS (1)
- Conditions
- Diabetic Retinal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 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.
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild center-involved diabetic macular edema | Active comparator | Drug: Anti-Vascular Endothelial Growth FactorEyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
| Moderate Center-involved diabetic macular edema | Active comparator | Drug: Anti-Vascular Endothelial Growth FactorEyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
| Severe Center-involved diabetic macular edema | Active comparator | Drug: Anti-Vascular Endothelial Growth FactorSevere CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosed with Type 1 or Type 2 diabetes
- Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
- At least 1 eye with CI-DME requiring treatment
- Able and willing to provide informed consent.
Key exclusion criteria (6 listed)
- Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
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 |
|---|---|---|
| Anti-Vascular Endothelial Growth FactorAlso: Anti-VEGFAll study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection). | Drug | Mild center-involved diabetic macular edema, Moderate Center-involved diabetic macular edema, Severe Center-involved diabetic macular edema |
Primary outcome
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Time frame: Baseline to 1 year
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Change in area under the log contrast sensitivity function (AULCSF)
Time frame: Baseline to 1 year
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Change in electroretinography parameter
Time frame: Baseline to 1 year
Measured by the RETeval device
Change in reading performance
Time frame: Baseline to 1 year
Measured by the MNREAD test
Change in visual field function
Time frame: Baseline to 1 year
Measured by Humphrey Visual Field testing
Change in diabetic retinopathy severity
Time frame: Baseline to 1 year
Assessed by ultra-widefield (UWF) color fundus photography
Change in retinal vascular pathology
Time frame: Baseline to 1 year
Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Change in retinal structure
Time frame: Baseline to 1 year
measured by optical coherence tomography (OCT)
Change in retinal microvascular parameter
Time frame: Baseline to 1 year
Measured by optical coherence tomography angiography (OCTA)
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 23 Oct 2026.
Related trials for Diabetic Retinal Disease
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
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Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Retina Consultants of Southern California
Huntington Beach, United States
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-Vascular Endothelial Growth Factor in people with Diabetic Retinal Disease, run by Jaeb Center for Health Research at 8 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 5 inclusion and 6 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 23 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 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in multifocal pupillographic objective perimetry (mfPOP) response delays (time frame: Baseline to 1 year). The study lists 9 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 23 Oct 2026.