Metformin vs. no treatment in the progression of geographic atrophy (GA), a type of age-related macular eye degeneration (AMD)

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"Can Metformin, used to treat Diabetes, slow the progression of geographic atrophy in patients with age-related macular eye degeneration?"
Age:
55-100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
age-related macular degeneration (AMD), Geographic atrophy (GA)
Type:
Drug study, Phase 2
Investigator:
Description
The purpose of this study is to evaluate the safety and efficacy of taking the oral drug metformin to slow the progression of GA, compared to the current standard of care which is no treatment. In this study, you will either be asked to take metformin twice daily or you will not take this drug and we will simply observe the progression of your GA as we would normally. Metformin is not FDA approved for this indication. Metformin is an FDA approved drug for the treatment of type 2 diabetes.
This study requires
Eye exams
Ocular imaging
Blood test
Study medication administration
Follow- up visit
Who can participate?
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):
Non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
Branch or central retinal vein or artery occlusion
Macular hole
Pathologic myopia
Uveitis
Pseudovitelliform maculopathy
Intra-operative surgery within the last 90 days prior to study eye enrollment
Benefits and risks of participating
If you are in the group that receives the study drug and it proves to slow the progression of your AMD, you may benefit from participating in the study, but this cannot be guaranteed.


You may have side effects while on the study. Everyone taking part in the study will be watched
carefully for any side effects. However, doctors don't know all the side effects that may happen.
Side effects may be mild or very serious. Many side effects go away soon after you stop taking
the drug. In some cases, side effects can be serious, long lasting, or may never go away.
It should be noted that metformin often causes gastrointestinal discomfort when it is initially
taken, but this generally decreases or goes away within the first few weeks of taking the drug, as
your body adjusts. This is why the dosage prescribed is smaller during the first few weeks of the
study.
You should talk to your study doctor about any side effects you experience while taking part in
the study.
Risks and side effects related to metformin include the following:
Likely
 Diarrhea
 Nausea
 Gas
 Head Pain
 Stomach Cramps
 Swelling of the Abdomen
 Taste Problems
 Vomiting
Less Likely
 Chills
 Dizzy
 Excessive Sweating
 Fingernail and/or Toenail Disease
 Flu-Like Symptoms
 Heart Throbbing or Pounding
 Incomplete or Infrequent Bowel Movements
 Indigestion
 Inflammation of the Nose
 Muscle Pain
 Rash
 Temporary Redness of Face and Neck
 Trouble breathing
 Inadequate Vitamin B12
Rare but serious—these side effects are extremely rare and generally are the result of an
overdose. Seek emergent medical attention should you experience any of these side-effects, as
left untreated they could result in death
 Increased Blood Acidity due to High Levels of Lactic Acid (Lactic acidosis)
 Low Blood Sugar
 Megaloblastic Anemia
 Reaction due to an Allergy
 Randomization risks: You will be assigned to a treatment program by chance, and the
treatment you receive may prove to be less effective or to have more side effects than the
other study treatment(s) or other available treatments.
 Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort
from the needle stick, bruising, infection, and fainting.
 Unknown Risks: The experimental treatments may have side effects that no one knows
about yet. The researchers will let you know if they learn anything that might make you
change your mind about participating in the study.
 For more information about risks and side effects, ask your study doctor.
Resources
Schedule
Study duration and period
Treatment: 1.5 years Follow-up: One visit
Recruitment period
From Oct. 20, 2016
Location
UC Davis Eye Center
4860 Y Street
2400
Sacramento, CA 95817
Contact
Denise Macias

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