Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Study ID
- NCT01309451
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGintravitreal, 1.25mg., monthly
- dexamethasone intravitreal implant — DRUG0.7mg, intravitreal every 4 months
Study Details
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Key Dates
- First listed
- Mar 7, 2011
- Start date
- Mar 31, 2011
- Status verified
- Oct 2014
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Bevacizumab alone
- Active Comparator: Combined groupBevacizumab plus Ozurdex
Primary Outcome Measure
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline [ Time Frame: baseline to 12 month ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Raj K. Maturi, MD | Indianapolis | Indiana | 46290 | - |
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