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

Santen

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Choroidal Neovascularization; Age-related Macular Degeneration

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712491

AMD-002

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include, but are not limited to:

• Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
• Visual acuity of 20/50 to 20/200 in study eye

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

2

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus