This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- Visual Acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Macular Thickness (OCT) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
- Vessel leakage (FA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
- Time to retreatment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Estimated Enrollment:
250
Study Start Date:
May 2007
Estimated Study Completion Date:
December 2009
Estimated Primary Completion Date:
December 2009 (Final data collection date for primary outcome measure)
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1: Experimental
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Drug: Dexamethasone
Intravitreal injection of Dexamethasone; 700 µg every 6 months; up to 2 doses
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2: Sham Comparator
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Drug: Sham injection
Sham injection every 6 months; up to 2 doses
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Purpose
