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Registry update — unassessed

Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration

Trial registry update: COMPLETED. Results are posted in the registry; assessment pending.

OTHERNotable significance
Reporter brief

What this changes

The finding has not established an approved change to our evidence assessment.

Source date: Jul 14, 2020 · Discovered: Sep 19, 2026 · Assessed: — · Historical research backfill

What it does not prove

  • The abstract provides no results, effect sizes, or efficacy data—only the study protocol and rationale
  • The pilot design and lack of a control group mean no causal conclusion about sirolimus efficacy can be drawn
  • The study's findings on safety and any vision preservation outcomes are not reported here

Extracted from supplied source material; model confidence is not a measured probability of correctness.

Design
Other
Sample size
—
Duration
36 months
Population
People with geographic atrophy (GA) in both eyes with visual acuity between 20/20 and 20/400 in each eye; women of childbearing potential are eligible (implied by pregnancy testing)
Primary outcome
Safety of subconjunctival sirolimus and vision preservation in patients with bilateral geographic atrophy
Effect size
—
Significance
Not reported
Journal
National Eye Institute (NEI)
Published
Jul 14, 2020

Recorded source passages

Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.

This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients.
People with GA in both eyes with visual acuity between 20/20 and 20/400 in each eye may be eligible for this study.
Sirolimus injections in the study eye at each 3-month clinic visit.
11 to 15 visits over 2 to 3 years

Source versions

Version 1: Superseded

Version 1: Unassessed

Assessment history

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