Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.

Detailed Description
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The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

Official Title
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Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: intravitreal injection of bevacizumab
* Procedure: panretinal photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symmetric proliferative diabetic retinopathy without high risk characteristics age 18 years or older patient consent Exclusion Criteria: heart attack or cerebrovascular attack only eye retinal detachment vitreous haemorrhage previous treatment for diabetic retinopathy media opacities that preclude visualization of the fundus pregnancy inability to understands the implications of the protocol

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intravitreal injection of bevacizumab|nan|
|Procedure: panretinal photocoagulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity at six months and one year |  |  | 
| Macular thickness measured by OCT at six months and one year |  |  | 
| Median deviation in visual fields at one year |  |  | 
| Score on a patient satisfaction scale at six months and one year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications associated to each treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, bevacizumab, photocoagulation