Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents

NCT07567833 — Phase 4, Recruiting, 100 participants, Jaeb Center for Health Research

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Registry	NCT07567833, acronym AS
Status	Recruiting
Phase	Phase 4
Study type	Interventional; non randomized, single group, masking: none, other
Enrollment	100 (Estimated)
Sponsor	Jaeb Center for Health Research (Other); collaborators: National Eye Institute (NEI)
Conditions	Diabetic Retinal Disease
Interventions	Anti-Vascular Endothelial Growth Factor (Drug)
Dates	start 2026-07-31, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-05-05, last updated 2026-09-18
Locations	6 sites in United States

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Mild center-involved diabetic macular edema	Active comparator	Drug: Anti-Vascular Endothelial Growth Factor	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
Moderate Center-involved diabetic macular edema	Active comparator	Drug: Anti-Vascular Endothelial Growth Factor	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
Severe Center-involved diabetic macular edema	Active comparator	Drug: Anti-Vascular Endothelial Growth Factor	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

Anti-Vascular Endothelial Growth Factor (Drug), also known as 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).

+Outcome measures

Primary outcomes

Change in multifocal pupillographic objective perimetry (mfPOP) response delays [Baseline to 1 year]: mfPOP response delays measured using the Objective Field Analyzer (OFA)
Change in area under the log contrast sensitivity function (AULCSF) [Baseline to 1 year]: AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Change in electroretinography parameter [Baseline to 1 year]: Measured by the RETeval device
Change in reading performance [Baseline to 1 year]: Measured by the MNREAD test
Change in visual field function [Baseline to 1 year]: Measured by Humphrey Visual Field testing
Change in diabetic retinopathy severity [Baseline to 1 year]: Assessed by ultra-widefield (UWF) color fundus photography
Change in retinal vascular pathology [Baseline to 1 year]: Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Change in retinal structure [Baseline to 1 year]: measured by optical coherence tomography (OCT)
Change in retinal microvascular parameter [Baseline to 1 year]: Measured by optical coherence tomography angiography (OCTA)

+Eligibility

Sex: All, ages: 18 Years to any

Key inclusion criteria:

* 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:

* 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

+Locations (6)

Facility	City	Country	Status
Southeast Retina Center, P.C.	Augusta, Georgia	United States	Recruiting
Boston Medical Center Corporation	Boston, Massachusetts	United States	Recruiting
Henry Ford Health System	Detroit, Michigan	United States	Recruiting
Mayo Clinic	Rochester, Minnesota	United States	Recruiting
Retina-Vitreous Consultants, Inc.	Monroeville, Pennsylvania	United States	Recruiting
Pittsburgh Clinical Trial Consortium	Sewickley, Pennsylvania	United States	Recruiting

+Funding

NIH grants: UG1EY014231