Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- Rocky Mountain Retina Consultants
- Study ID
- NCT00387582
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab (Lucentis) — DRUGLucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
- Argon Laser — PROCEDUREArgon laser at entry to trial and then per protocol for the duration of the study.
Study Details
This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.
Key Dates
- First listed
- Oct 13, 2006
- Start date
- Jul 31, 2006
- Status verified
- May 2014
- Primary completion
- Feb 28, 2009
- Completion
- Feb 28, 2009
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ILucentis injections for the first three months of the study and then per the protocol for the duration of the trial.
- Active Comparator: IIArgon Laser treatment at enrollment and then per the protocol for the duration of the study.
Primary Outcome Measure
Prevention of vision loss at one year as evidenced by ETDRS visual acuity. [ Time Frame: 6 and 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | - |
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