Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

Official Title
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Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy

Conditions
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Diabetic Retinopathy, Retinal Neovascularization

Intervention / Treatment
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* Drug: Ranibizumab
* Procedure: Panretinal Photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old High risk proliferative diabetic retinopathy Visual acuity ≥ 20/800 No previous laser treatment for diabetic retinopathy Exclusion Criteria: Previous pars plana vitrectomy Systemic thrombo-embolic events Uncontrolled systemic hypertension Conditions avoiding adequated documentation Previous eye surgery in the last 6 months before inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP plus ranibizumab<br>Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab | Drug: Ranibizumab<br>* Ranibizumab (Lucentis), intravitreal injections of 0.05ml<br>* Other names: Lucentis;Procedure: Panretinal Photocoagulation<br>* Panretinal photocoagulation with green laser according to ETDRS<br>|
| Active Comparator: PRP<br>Patients will only be submitted to panretinal photocoagulation | Procedure: Panretinal Photocoagulation<br>* Panretinal photocoagulation with green laser according to ETDRS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein leakage area (mm2) | Neovascularization area measured during fluorescein agiography middle phase | Week 48 after inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMT | Macular thickness measured with Stratus OCT protocols | Week 48 after inclusion in the study | 
| LogMAR BCVA | LogMAR best corrected visual acuity measured with ETDRS charts | Week 48 after inclusion in the study | 
| Retina mid periphery visual field sensitivity change |  | Week 48 after inclusion in the study | 
| Rod pathway integrity and oscillatory potential amplitudes |  | Week 48 after inclusion in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser