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Avastin for PDR (Proliferative Diabetic Retinopathy)

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Detachment; Diabetic Retinopathy

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

Phase: N/A

Status: Completed

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
Dean Eliott, MD, Principal Investigator, Affiliation: University of Southern California


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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The effect of an anti-VEGF agent, bevacizumab, on growth factor levels in eyes with traction retinal detachment due to PDR.

Secondary outcome:

To determine whether intra- and post-operative complications are decreased in eyes given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery.

Visual outcomes are improved in patients given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University of Southern California, Los Angeles, California 90033, United States
Additional Information

Starting date: June 2009
Last updated: January 16, 2013

Page last updated: August 20, 2015

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