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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Conditions
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Age-Related Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
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* Drug: Sirolimus in combination with ranibizumab
* Drug: Sirolimus in combination with ranibizumab
* Drug: Placebo in combination with ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Group 1<br> | Drug: Sirolimus in combination with ranibizumab<br>* Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.<br>* Other names: Lucentis;|
| Experimental: Dose Group 2<br> | Drug: Sirolimus in combination with ranibizumab<br>* Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.<br>* Other names: Lucentis;|
| Placebo Comparator: Dose Group 3<br> | Drug: Placebo in combination with ranibizumab<br>* Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness |  | 120 days | 
| Safety across treatment groups |  | Through 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet AMD