Avastin for PDR (Proliferative Diabetic Retinopathy)

Diabetic Retinopathy Clinical Trial

— PDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270542
• Other study ID #: USC-HS-09-00068
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: January 16, 2013
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases

Intervention

Drug:
• Avastin (bevacizumab)
single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Other:
• Sham injection
Subject's eyes will be anesthetized but no injection will be performed.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of an anti-VEGF agent, bevacizumab, on growth factor levels in eyes with traction retinal detachment due to PDR.		Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery.	No
Secondary	To determine whether intra- and post-operative complications are decreased in eyes given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery.		Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery.	No
Secondary	Visual outcomes are improved in patients given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery.		Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery.	No