Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
NCT ID: NCT00766337
Last Updated: 2013-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2008-12-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dose Group 1
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.
Dose Group 2
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.
Dose Group 3
Placebo in combination with ranibizumab
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Interventions
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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.
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.
Placebo in combination with ranibizumab
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity of 20/40 to 20/200 in the study eye
Exclusion Criteria
* Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
50 Years
ALL
No
Sponsors
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MacuSight, Inc.
INDUSTRY
Santen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Naor, MD
Role: STUDY_DIRECTOR
MacuSight, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Countries
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Other Identifiers
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AMD-003
Identifier Type: -
Identifier Source: org_study_id
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