Registry update — unassessed
Pilot Study of the Evaluation of Intravitreal 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
What this changes
The finding has not established an approved change to our evidence assessment.
Source date: Jul 7, 2021 · Discovered: Sep 19, 2026 · Assessed: — · Historical research backfill
What it does not prove
- This pilot study has not reported its results, making it impossible to determine whether sirolimus was actually safe or effective for GA.
- Without a control group or comparison arm, any safety or efficacy findings would reflect only the treated population and could not determine whether sirolimus caused observed changes.
- The study design and abstract do not indicate whether vision preservation or other clinical outcomes were measured or how they were assessed.
Extracted from supplied source material; model confidence is not a measured probability of correctness.
Study details
- Design
- Other
- Sample size
- —
- Duration
- 12 months
- Population
- People at least 56 years of age with geographic atrophy related to age-related macular degeneration in both eyes
- Primary outcome
- Safety and vision preservation in patients with geographic atrophy
- Effect size
- —
- Significance
- Not reported
- Journal
- National Eye Institute (NEI)
- Published
- Jul 7, 2021
Sources
Primary source
- National Eye Institute (NEI) ↗Clinical trial
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 whether a drug called sirolimus is safe to give to people with geographic atrophy (GA) and if it can help preserve vision in patients.
This study requires at least 8 visits to the National Eye Institute over 1 year. Study visits will be every 2 months for 1 year.
Participants will have a sirolimus injection into the study eye at the first visit and every 2 months thereafter unless contraindicated.
Source versions
Assessment history
Discussion (0)
One thread per scientific event, no matter how many outlets covered it.
Sign in to join the discussion.
No comments yet
Be the first to weigh in on this evidence.