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Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Sponsor: Jaeb Center for Health Research
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-07-31
Completion Date
2027-12
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Anti-Vascular Endothelial Growth Factor
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).
Locations (8)
Retina Consultants of Southern California
Huntington Beach, California, United States
Southeast Retina Center, P.C.
Augusta, Georgia, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States
Pittsburgh Clinical Trial Consortium
Sewickley, Pennsylvania, United States
Retina Consultants of Texas
Beaumont, Texas, United States