Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy
- Sponsor
- José Cunha-Vaz
- Study ID
- NCT01280929
- Phase
- PHASE2
- Status
- Completed
Conditions
- High Risk Proliferative Diabetic Retinopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Panretinal Photocoagulation (PRP) — PROCEDURE
- Intravitreous injection of ranibizumab — DRUG
Study Details
The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.
Key Dates
- First listed
- Jan 21, 2011
- Start date
- Sep 30, 2010
- Status verified
- Oct 2015
- Primary completion
- Dec 31, 2013
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 54 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Panretinal Photocoagulation (PRP)Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.
- Experimental: RanibizumabGroup 2: Intravitreous injections of ranibizumab every 4 weeks at month-0, month-1 and month-2 that can be repeated after month-3.
- Experimental: Ranibizumab + Panretinal Photocoagulation (PRP)Group 3: Combination treatment of ranibizumab intravitreous injections plus PRP (2 weeks +/- 1 week after injection), at month-0, month-1 and month-2 that can be repeated after month-3.
Primary Outcome Measure
Regression of neovascularization [ Time Frame: 12-month treatment ]