Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Age-Related Macular Degeneration, Choroidal Neovascularization

In brief

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.

Key facts

Study ID

NCT00766337

Run by

Santen Inc.

People needed

62

Starts

2008-12-01

Expected to finish

2010-03-01

Last updated by the study team

2013-01-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
• Visual acuity of 20/40 to 20/200 in the study eye

You may not qualify if…

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

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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