Longitudinal retinal function study in eyes treated for diabetic macular edema with anti-VEGF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4 interventional trial examining retinal structure and function in people with diabetic retinal disease treated with anti-VEGF agents. The study aims to help identify meaningful endpoints for regulatory trials by tracking structural and functional retinal changes. Eligible participants are adults with diabetes and at least one eye with center-involved diabetic macular edema requiring treatment, who will receive anti-VEGF therapy as part of standard care within the study framework. Imaging and vision assessments will be used to correlate anatomical changes with functional outcomes, under approved protocols and informed consent. Exclusion criteria remove individuals with conditions or recent surgeries that could confound retinal measurements.

Why it matters

Who can join: the full rules

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

Where it's running

• Retina Consultants of Southern California
  Huntington Beach, California, United States Recruiting
• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.