Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
|ClinicalTrials.gov Identifier: NCT01746563|
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases||Drug: Ranibizumab Procedure: Laser therapy||Phase 1 Phase 2|
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).
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).
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Ranibizumab 0,05 mg intravitreal injection
Other Name: Lucentis (Novartis)Procedure: Laser therapy
Active Comparator: Laser Therapy
Laser Therapy alone
Procedure: Laser therapy
- Macular Evaluation [ Time Frame: 6 Months ]Changes between visual acuity from baseline to month 6.
- Structural Macular Evaluation [ Time Frame: 06 months ]Change on retinal thickness between baseline and Month 6
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746563
|Universidade of Sao Paulo|
|Sao Paulo, Brazil, 05403-000|
|Principal Investigator:||Walter Y Takahashi, PhD||University of Sao Paulo|