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

Santen Inc.1 site in 1 country20 target enrollmentSeptember 2008

ConditionsAge-related Macular Degeneration Choroidal Neovascularization

InterventionsSirolimus

DrugsSirolimus

Overview

Phase: Phase 1
Intervention: Sirolimus
Conditions: Age-related Macular Degeneration
Sponsor: Santen Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Best-corrected visual acuity by ETDRS
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

March 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Any other ocular disease that could compromise vision in the study eye
•History of any prior treatment for choroidal neovascularization in the study eye
•Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration