Registry update — unassessed
A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Trial registry update: TERMINATED. No results reported in the supplied registry record.
RCTNotable significance
What this changes
The finding has not established an approved change to our evidence assessment.
Source date: Jan 10, 2013 · Discovered: Sep 19, 2026 · Assessed: — · Historical research backfill
What it does not prove
- No efficacy results are reported, so the actual effect of rapamycin addition on vision or disease progression cannot be determined from this source
- Sample size is unstated, limiting assessment of statistical power and reliability of any results
- As a phase 2 trial, findings would require confirmation in adequately powered phase 3 trials before clinical significance can be established
Extracted from supplied source material; model confidence is not a measured probability of correctness.
Study details
- Design
- Rct
- Sample size
- —
- Duration
- —
- Population
- Patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
- Primary outcome
- Safety and efficacy of ocular sirolimus formulation in combination with Lucentis
- Effect size
- —
- Significance
- Not reported
- Journal
- Santen Inc.
- Published
- Jan 10, 2013
Sources
Primary source
- Santen Inc. ↗Clinical trial
Recorded source passages
Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.
A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
Source versions
Assessment history
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