Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
Age-related Macular Degeneration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration|
- Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Best-corrected visual acuity by ETDRS [ Time Frame: 60 days, 120 days ] [ Designated as safety issue: No ]
- Safety across injection routes [ Time Frame: Through 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Three subconjunctival injections of 1320 micrograms sirolimus each.
Other Name: MS-R002, rapamycin
Three intravitreal injections of 352 micrograms sirolimus each.
Other Name: MS-R001, rapamycin