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Sponsored by: |
MacuSight, Inc. |
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Information provided by: | MacuSight, Inc. |
ClinicalTrials.gov Identifier: | NCT00766337 |
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.
Condition | Intervention | Phase |
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Age-Related Macular Degeneration Choroidal Neovascularization |
Drug: Sirolimus in combination with ranibizumab Drug: Placebo in combination with ranibizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose Group 1: Experimental |
Drug: Sirolimus in combination with ranibizumab
Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
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Dose Group 2: Experimental |
Drug: Sirolimus in combination with ranibizumab
Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
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Dose Group 3: Placebo Comparator |
Drug: Placebo in combination with ranibizumab
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Celine Delpouys | 510-400-1440 | cdelpouys@macusight.com |
United States, Arizona | |
Retinal Consultants of Arizona | Recruiting |
Phoenix, Arizona, United States, 85014 | |
Contact: Elena Baj 602-222-2221 ext 131 ebaj@retinalconsultantsaz.com | |
Principal Investigator: Derek Kunimoto, MD |
Study Director: | Joel Naor, MD | MacuSight, Inc. |
Responsible Party: | MacuSight ( Kathy Jensen/Director of Clinical Operations ) |
Study ID Numbers: | AMD-003 |
Study First Received: | October 1, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00766337 History of Changes |
Health Authority: | United States: Food and Drug Administration |
wet AMD |
Sirolimus Immunologic Factors Clotrimazole Miconazole Eye Diseases Choroid Diseases Tioconazole Macular Degeneration Retinal Degeneration |
Immunosuppressive Agents Choroidal Neovascularization Anti-Bacterial Agents Metaplasia Antifungal Agents Neoplasm Metastasis Neovascularization, Pathologic Retinal Diseases |
Sirolimus Anti-Infective Agents Uveal Diseases Immunologic Factors Antineoplastic Agents Eye Diseases Physiological Effects of Drugs Choroid Diseases Macular Degeneration Retinal Degeneration Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Choroidal Neovascularization Anti-Bacterial Agents Pathologic Processes Antifungal Agents Therapeutic Uses Metaplasia Neovascularization, Pathologic Retinal Diseases |