Avastin for PDR (Proliferative Diabetic Retinopathy)

University of Southern California

Status: Completed

Conditions: Retinal Detachment; Diabetic Retinopathy

Treatments: Other: Sham injection; Drug: Avastin (bevacizumab)

Study type: Interventional

Funder types: Other

Identifiers

NCT01270542

USC-HS-09-00068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Avastin Injection Group (AIG)

Experimental group

Description:

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.

Treatment:

Drug: Avastin (bevacizumab)

Sham Injection Group (SIG)

Sham Comparator group

Description:

Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Treatment:

Other: Sham injection