Tracking Retina Function in Eyes Treated With Anti-VEGF Drugs for Diabetic Macular Edema
Follows retina changes in adults with diabetic eye disease receiving anti-VEGF treatment.
Plain-language title generated from the registry record
Registry title: Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Key facts
- Where
- Augusta, Beaumont, Boston, Detroit, Huntington Beach, Monroeville, Rochester, and Sewickley, United StatesSee the 8 sites
- Phase
- Phase 4
Where in United States
- Southeast Retina Center, P.C.Augusta, United StatesTaking people
- Retina Consultants of TexasBeaumont, United StatesTaking people
- Boston Medical Center CorporationBoston, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Retina Consultants of Southern CaliforniaHuntington Beach, United StatesTaking people
- Retina-Vitreous Consultants, Inc.Monroeville, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Pittsburgh Clinical Trial ConsortiumSewickley, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jaeb Center for Health Research
- Trial code
- NCT07567833
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
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.
Inclusion: 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.
Exclusion: Previous treatment of any kind for diabetic retinopathy or DME; Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months; 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; 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.