Avastin for PDR (Proliferative Diabetic Retinopathy)

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sham Injection Group (SIG)	Sham injection	Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
Avastin Injection Group (AIG)	Avastin (bevacizumab)	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.

Primary Outcome Measures

Name	Time	Method
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	3 months after last surgery	Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.

Secondary Outcome Measures

Name	Time	Method
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.	3 months from last surgery	Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)