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

Phase 4RecruitingNCT07567833

Jaeb Center for Health Research100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Diabetic Retinal Disease

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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