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NCT07567833PHASE4Recruiting

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

Jaeb Center for Health Research

Start Date

7/31/2026

Completion Date

12/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Anti-Vascular Endothelial Growth Factor

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Conditions

Diabetic Retinal Disease

Locations

Southeast Retina Center, P.C.

Augusta, Georgia 30909

United States

Boston Medical Center Corporation

Boston, Massachusetts 02118

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania 15146

United States

Pittsburgh Clinical Trial Consortium

Sewickley, Pennsylvania 15143

United States