Clinical Trials Directory

Trials / Terminated

TerminatedNCT00712491

Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

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

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Santen Inc. · Industry
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGSirolimusThree subconjunctival injections of 1320 micrograms sirolimus each.
DRUGSirolimusThree intravitreal injections of 352 micrograms sirolimus each.

Timeline

Start date
2008-09-01
Primary completion
2009-11-01
Completion
2010-03-01
First posted
2008-07-10
Last updated
2013-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00712491. Inclusion in this directory is not an endorsement.

Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration (NCT00712491) · Clinical Trials Directory