A Phase 1/2 interventional study of Ranibizumab and Laser therapy in Diabetic Retinopathy, Retinal Diseases and Eye Diseases, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by University of Sao Paulo · Phase 1/2, Interventional, and Treatment
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).
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
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Ranibizumab 0,05 mg intravitreal injection
Drug: Ranibizumab · Procedure: Laser therapy
Laser Therapy alone
Procedure: Laser therapy
Intravitreal injection
Also known as: Lucentis (Novartis)
Laser therapy
Macular Evaluation
Changes between visual acuity from baseline to month 6.
Time frame: 6 Months
Structural Macular Evaluation
Change on retinal thickness between baseline and Month 6
Time frame: 06 months
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo