Ranibizumab as a Rescue Therapy for Diabetic Macular Edema
Part of paid clinical trials in Norwich, Connecticut.
- Sponsor
- New England Retina Associates
- Study ID
- NCT01253694
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- injection of 0.5 mg of Intravitreal Ranibizumab — DRUGFollowing the sterile technique, intravitreal injection of anti-VEGF is applied
Study Details
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
Key Dates
- First listed
- Dec 3, 2010
- Start date
- Mar 31, 2011
- Status verified
- May 2013
- Primary completion
- Jun 30, 2012
- Completion
- Jul 31, 2012
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Patients with 3-5 consecutive Avastin injectionsThese patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.
- Experimental: Patients with 6 or more consecutive injections of BevacizumabPatients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months.
Primary Outcome Measure
Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns. [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New England Retina Associates | Norwich | Connecticut | 06360 | - |
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