Trial · NCT02684578

Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD

NCT02684578, Phase 2, Completed, University of California, San Francisco; results first posted 2023-06-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD. Trials, record NCT02684578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684578

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
NCT number: NCT02684578
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Age-Related Macular Degeneration, Macular Degeneration, Age-Related, Dry Macular Degeneration, Geographic Atrophy
Interventions: Metformin
First posted: 2016-02-18
Last updated: 2023-06-09
Results first posted: 2023-06-09

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy	0 months, 18 months	The primary efficacy endpoint was the annualized growth rate of the square root of geographic atrophy (GA) area in mm/year in the study eye as imaged by fundus autofluorescence (FAF) imaging. Change = (Month 18 GA Area - Baseline GA Area).
Secondary	Change in Best Corrected Visual Acuity (BCVA)	0 months, 18 months	BCVA is the best possible vision an eye can see with corrective lenses and is measured as then number of letters read on the ETDRS chart. Change = (Month 18 Score - Baseline Score).
Secondary	Change in Low-luminance Visual Acuity (LLVA)	0 months, 18 months	LLVA involves standard BCVA testing in low-light conditions, which is achieved by adding a neutral density filter in front of the eye being tested. LLVA is measured as the number of letters read on the ETDRS chart. This measure has been shown to correlate well with enlargement of GA. Change = (Month 18 Score - Baseline Score).
Secondary	Ocular Safety as Measured by the Presence of Novel Intraocular Inflammation Judged by the Investigator to be Due to the Study Drug Metformin	0 months, 6 months, 12 months, 18 months, 24 months	Subjects assigned to the Metformin study arm will be assessed at each follow-up eye exam to confirm ocular safety of metformin. The Data Safety and Management Board for this study will also assess the safety of metformin at different time points throughout the study. They will formally meet to discuss study subject safety at 25% enrollment and 75% enrollment. The potential for ocular side effects due to metformin is thought to be very low, due to the large number of diabetic patients who take this drug and are followed closely for diabetic retinopathy or other ocular disease. This outcome measures the number of treatment arm patients who experienced adverse ocular events during 1 or more follow-up visits.
Secondary	Systemic Safety as Measured by Presence of Side Effects Listed on Metformin Drug Label as "Severe"	0 months, 6 months, 12 months, 18 months, 24 months	These include: Infrequent side effects of metformin (severe): * Trouble Breathing Rare side effects of metformin (severe): * Increased Blood Acidity due to High Levels of Lactic Acid (Lactic acidosis) * Low Blood Sugar * Megaloblastic Anemia * Reaction due to an Allergy Subjects assigned to the Metformin study arm will be assessed for these side-effects at each follow-up eye exam to confirm ocular safety of metformin. The Data Safety and Management Board for this study will also assess the safety of metformin at different time points throughout the study. They will formally meet to discuss study subject safety at 25% enrollment and 75% enrollment. This outcome measures the number of treatment arm patients who experienced side effects listed on Metformin drug label as "severe" during 1 or more follow-up visits.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy	0 months, 18 months	mm/year	MEAN
SECONDARY	Change in Best Corrected Visual Acuity (BCVA)	0 months, 18 months	letters correctly read	MEAN
SECONDARY	Change in Low-luminance Visual Acuity (LLVA)	0 months, 18 months	letters correctly read	MEAN
SECONDARY	Ocular Safety as Measured by the Presence of Novel Intraocular Inflammation Judged by the Investigator to be Due to the Study Drug Metformin	0 months, 6 months, 12 months, 18 months, 24 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Systemic Safety as Measured by Presence of Side Effects Listed on Metformin Drug Label as Severe	0 months, 6 months, 12 months, 18 months, 24 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy	Metformin	0.41	Standard Deviation 0.05	mm/year
Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy	Observation	0.35	Standard Deviation 0.05	mm/year
Change in Best Corrected Visual Acuity (BCVA)	Metformin	-3.2	Standard Error 0.9	letters correctly read
Change in Best Corrected Visual Acuity (BCVA)	Observation	-3.2	Standard Error 1.3	letters correctly read
Change in Low-luminance Visual Acuity (LLVA)	Metformin	-2.1	Standard Error 2.0	letters correctly read
Change in Low-luminance Visual Acuity (LLVA)	Observation	-6.3	Standard Error 1.9	letters correctly read
Ocular Safety as Measured by the Presence of Novel Intraocular Inflammation Judged by the Investigator to be Due to the Study Drug Metformin	Metformin	0		Participants
Systemic Safety as Measured by Presence of Side Effects Listed on Metformin Drug Label as Severe	Metformin	0		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Metformin	32	53
Overall Study	STARTED	Observation	34	57
Overall Study	COMPLETED	Metformin	21	34
Overall Study	COMPLETED	Observation	23	37
Overall Study	NOT COMPLETED	Metformin	11	19
Overall Study	NOT COMPLETED	Observation	11	20

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Gastrointestinal discomfort	Gastrointestinal disorders	Metformin	5	32	5
other	Gastrointestinal discomfort	Gastrointestinal disorders	Observation	0	34	0
other	Diarrhea	Gastrointestinal disorders	Metformin	5	32	5
other	Diarrhea	Gastrointestinal disorders	Observation	1	34	1
other	Chest pain	General disorders	Metformin	2	32	2
other	Chest pain	General disorders	Observation	0	34	0
other	Abdominal pain	Gastrointestinal disorders	Metformin	1	32	1
other	Abdominal pain	Gastrointestinal disorders	Observation	1	34	1
other	Fatigue	General disorders	Metformin	2	32	2
other	Fatigue	General disorders	Observation	0	34	0

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin	0	32
Total, all-cause mortality	Observation	2	34
Total, other adverse events	Metformin	16	32
Total, other adverse events	Observation	4	34
Total, serious adverse events	Metformin	5	32
Total, serious adverse events	Observation	3	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metformin vs Observation: deaths from any cause	Trial comparisons
Metformin vs Observation: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02684578

GET https://conductscience.org/api/trials/v1/NCT02684578/events?page=2

API reference For AI assistants