Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
Condition: Age-Related Macular Degeneration; Macular Degeneration, Age-Related; Dry Macular Degeneration; Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Metformin
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be >/= 55 years of age

          -  Subject must have evidence of advanced dry AMD, defined by the characteristic presence
             of drusen and/or pigmentary changes as well as geographic atrophy

          -  Subject must have clear ocular media and adequate pupillary dilation

          -  Subject must be able to swallow capsules

          -  Study eye must have best corrected visual acuity (BCVA) of 20/20-20/400

          -  Subject must be willing and able to pay for monthly prescription of Metformin HCl for
             18 months in the event that their insurance carrier will not cover the cost of the
             drug

        Exclusion Criteria:

          -  Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2
             (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as one or more
             well-defined and often circular patches of partial or complete depigmentation of the
             RPE, typically with exposure of underlying choroidal blood vessels. Even if much of
             the RPE appears to be preserved and large choroidal vessels are not visible, a round
             patch of RPE partial depigmentation may be classified as early GA. The GA in the study
             eye must be able to be photographed in its entirety, and it must not be contiguous
             with any areas of peripapillary atrophy, which can complicate area measurements.

          -  Subjects who are already taking metformin for another purpose

          -  Subjects with type 1 or 2 diabetes

          -  Subjects with compromised kidney function:

          -  Serum creatinine ≥1.5 mg/dL for males and ≥1.4 mg/dL for females

          -  Subjects with moderate to severe heart failure (Class III or IV, New York Heart
             Association Functional Classifications)

          -  Subjects with Child's class C cirrhosis

          -  Evidence of retinal atrophy due to causes other than atrophic AMD.

          -  Subjects who have had anti-VEGF injections or active choroidal neovascularization in
             the study eye during the last 12 months

          -  Current evidence or history of ocular disorders in the study eye that in the opinion
             of the investigator confounds study outcome measures, including (but not limited to):

               1. Non-proliferative diabetic retinopathy involving 10 or more hemorrhages or
                  microaneurysms, or active proliferative diabetic retinopathy

               2. Branch or central retinal vein or artery occlusion

               3. Macular hole

               4. Pathologic myopia

               5. Uveitis

               6. Pseudovitelliform maculopathy

               7. Intraoperative surgery within the last 90 days prior to study eye enrollment