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Completed

NCT Number: NCT01270542

Avastin for PDR (Proliferative Diabetic Retinopathy)

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).

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Key information

Conditions

Retinal Detachment Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avastin (Bevacizumab)

Drug

single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Other names: Avastin

Sham Injection

Other

Subject's eyes will be anesthetized but no injection will be performed.

Other names: Sham

Primary outcomes

  1. 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

    Time frame: 3 months after last surgery

    Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.

Secondary outcomes

  1. 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.

    Time frame: 3 months after last surgery.

  2. Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: PDR

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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