Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Brandon G. Busbee, MD
- Study ID
- NCT00533520
- Phase
- PHASE4
- Status
- Completed
Conditions
- Choroidal Neovascularization
- Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 95 Years
- Healthy Volunteers
- Accepted
Interventions
- ranibizumab — DRUGArm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
Study Details
Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).
Key Dates
- First listed
- Sep 21, 2007
- Start date
- Sep 30, 2007
- Status verified
- Nov 2013
- Primary completion
- Nov 30, 2013
- Completion
- Nov 30, 2013
Study Design
- Enrollment
- 37 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 0.5mg ranibizumabSubjects will be treated with 0.5mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
- Active Comparator: 1.0mg ranibizumabSubjects will be treated with 1.0mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
- Active Comparator: 2.0mg ranibizumabSubjects will be treated with 2.0 mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
Primary Outcome Measure
Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection [ Time Frame: 24 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tennessee Retina, P.C. | Nashville | Tennessee | 37203 | - |
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