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

NCT07567833 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Diabetic Retinal Disease

Interventions

DRUG

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).

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2033-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567833 on ClinicalTrials.gov