Clinical Trial: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy

Brief Summary: To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Detailed Summary:

Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).

Objectives:

Primary objective:

The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).

Secondary objectives:

To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.

To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.

Strategic goal:

The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome


Sponsor: University of Sao Paulo

Current Primary Outcome: Macular Evaluation [ Time Frame: 6 Months ]

Changes between visual acuity from baseline to month 6.


Original Primary Outcome: Same as current

Current Secondary Outcome: Structural Macular Evaluation [ Time Frame: 06 months ]

Change on retinal thickness between baseline and Month 6


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: December 6, 2012
Date Started: May 2011
Date Completion:
Last Updated: December 7, 2012
Last Verified: December 2012