Avastin for PDR (Proliferative Diabetic Retinopathy)

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Detailed Description
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Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Official Title
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Effect of Pre-operative Adjunctive Anti-VEGF on Growth Factors in Severe Proliferative Diabetic Retinopathy Requiring Surgical Management

Conditions
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Retinal Detachment, Diabetic Retinopathy

Intervention / Treatment
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* Drug: Avastin (bevacizumab)
* Other: Sham injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair. Exclusion Criteria: Dense vitreous hemorrhage Inability to follow-up for surgery within 3-7 days after intravitreal injection History of stroke, thromboembolic event, or heart attack within the last 6 months Less than 18 years of age Pregnancy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avastin Injection Group (AIG)<br>Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. | Drug: Avastin (bevacizumab)<br>* single 0.05 mL intravitreal injection of bevacizumab 1.25 mg<br>* Other names: Avastin;|
| Sham Comparator: Sham Injection Group (SIG)<br>Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. | Other: Sham injection<br>* Subject's eyes will be anesthetized but no injection will be performed.<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR | Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups. | 3 months after last surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery. |  | 3 months after last surgery. | 
| Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. | Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3) | 3 months from last surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traction Retinal Detachment (PDR), Proliferative Diabetic Retinopathy (PDR)