Trials / Completed
CompletedNCT02684578
Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
METforMIN: Metformin Administration for the Minimization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD).
Detailed 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 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.
Conditions
- Age-Related Macular Degeneration
- Macular Degeneration, Age-Related
- Dry Macular Degeneration
- Geographic Atrophy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2022-04-01
- Completion
- 2022-10-01
- First posted
- 2016-02-18
- Last updated
- 2023-06-09
- Results posted
- 2023-06-09
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02684578. Inclusion in this directory is not an endorsement.