The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- Time to retreat with ranibizumab [ Time Frame: 1-6 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual Acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Central Retinal Thickness (OCT) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Lesion size (FA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Quality of Life questionnaires [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Estimated Enrollment:
200
Study Start Date:
November 2007
Estimated Study Completion Date:
June 2009
Estimated Primary Completion Date:
June 2009 (Final data collection date for primary outcome measure)
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1: Experimental
adjunctive therapy of experimental with ranibizumab
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Drug: Dexamethasone and ranibizumab
Intravitreal injection of Dexamethasone 700µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14
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2: Sham Comparator
adjunctive therapy of sham (for masking) and ranibizumab
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Other: Sham injection and ranibizumab
sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14
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Purpose
