Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy
Public ClinicalTrials.gov record NCT01675947. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi-Center, Randomized, Single Masked Phase 2 Study of Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will seek to enroll 50 persons who have central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to receive one of the following treatments in the study eye: 1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or 2. A sham treatment (subconjunctival injection of lidocaine) Participants with two (2) eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and no sham in the fellow eye. The first injection will begin at Day 0, which may occur on the date of screening/enrollment or up to two weeks following screening/enrollment visit, and every month thereafter. The visit schedule is as follows: 1. A clinical evaluation, including safety measures, will occur monthly. 2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and 24 months after the first injection has occurred. 3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24 months after the first injection has occurred. 4. Fundus color photography and optical coherence tomography will occur at screening/enrollment and at 6, 12, 18 and 24 months after the first injection has occurred. The primary goal is to evaluate whether the persons receiving the sirolimus injections show a slower worsening of geographic atrophy compared to the persons receiving the sham injections. A secondary goal is to evaluate the impact of sirolimus on vision compared to the sham. NOTE: As of May 30, 2014, study injections were discontinued due to safety concerns. No further enrollments will occur and follow-up will continue on all active study participants on a quarterly basis. That is, on visits coinciding with 3 month intervals from date of enrollment.
Study identification
- NCT ID
- NCT01675947
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2012
- Primary completion
- May 31, 2015
- Completion
- Jan 31, 2016
- Last update posted
- Dec 9, 2015
2012 – 2016
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| University of Florida HSC | Jacksonville | Florida | 32209 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Elman Retina Group | Baltimore | Maryland | 21237 | — |
| Vision Research Foundation | Grand Rapids | Michigan | 49546 | — |
| Charlotte Eye Ear Nose & Throat Associates | Charlotte | North Carolina | 28210 | — |
| Scheie Eye Institute, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37909 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01675947, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2015 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01675947 live on ClinicalTrials.gov.