Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- Texas Retina Associates
- Study ID
- NCT01295112
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Non-Ischemic Central Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Active bevacizumab and Sham dexamethasone — DRUGBevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
- Active bevacizumab and Active dexamethasone — DRUGBevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
Study Details
This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.
Key Dates
- First listed
- Feb 14, 2011
- Start date
- May 31, 2011
- Status verified
- Sep 2017
- Primary completion
- Oct 31, 2015
- Completion
- Oct 31, 2015
Study Design
- Enrollment
- 68 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Sham Comparator: Group 1Active bevacizumab (Avastin®) and Sham Ozurdex®
- Active Comparator: Group 2Active bevacizumab (Avastin®) and Active Ozurdex®
Primary Outcome Measure
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks [ Time Frame: 24 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Retina Associates | Dallas | Texas | 75231 | - |
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