Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Age - Related Macular Degeneration
- Dry Macular Degeneration
- Geographic Atrophy
- Macular Degeneration (Age Related)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 125 years
- Gender
- Both males and females
Description
This is a phase II, single-blind, randomized, evaluation of the safety and efficacy of metformin use to decrease geographic atrophy (GA) progression in non-diabetic patients with dry Age-related Macular Degeneration (AMD). Approximately 186 study subjects throughout four separate study sites will be...
This is a phase II, single-blind, randomized, evaluation of the safety and efficacy of metformin use to decrease geographic atrophy (GA) progression in non-diabetic patients with dry Age-related Macular Degeneration (AMD). Approximately 186 study subjects throughout four separate study sites will be randomized in a 1:1 ratio to the treatment group and the observation group. The treatment group will be assigned to the study intervention (oral Metformin) for 18 months while the observation group will receive no intervention for 18 months, instead continuing with standard of care ophthalmic exams and close monitoring of their disease. There will be one additional follow up visit at 24 months. Throughout the 24 month study period, the progression of subjects' GA or drusen growth will be measured via ocular imaging taken at standard of care follow-up examinations, including fundus autofluorescence imaging, optical coherence tomography (OCT), and fundus photography.
Tracking Information
- NCT #
- NCT02684578
- Collaborators
- University of California, Los Angeles
- San Francisco Veterans Affairs Medical Center
- VA Palo Alto Health Care System
- University of California, Davis
- University of California, Irvine
- University of California, San Diego
- Northwestern University
- University of Illinois at Chicago
- Retinal Consultants Medical Group
- Retina Health Center
- California Retina Consultants
- Oregon Health and Science University
- Investigators
- Principal Investigator: Jay M Stewart, MD University of California, San Francisco