Avastin for PDR (Proliferative Diabetic Retinopathy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elliott Sohn, University of Southern California
ClinicalTrials.gov Identifier:
NCT01270542
First received: December 1, 2010
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Retinal Detachment
Diabetic Retinopathy
Drug: Avastin (bevacizumab)
Other: Sham injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pre-operative Adjunctive Anti-VEGF on Growth Factors in Severe Proliferative Diabetic Retinopathy Requiring Surgical Management

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • The effect of an anti-VEGF agent, bevacizumab, on growth factor levels in eyes with traction retinal detachment due to PDR. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether intra- and post-operative complications are decreased in eyes given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery. [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Visual outcomes are improved in patients given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin Injection Group (AIG)
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.
Drug: Avastin (bevacizumab)
single 0.05 mL intravitreal injection of bevacizumab 1.25 mg
Other Name: Avastin
Sham Comparator: Sham Injection Group (SIG)
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
Other: Sham injection
Subject's eyes will be anesthetized but no injection will be performed.
Other Name: Sham

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270542

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Dean Eliott, MD University of Southern California
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elliott Sohn, MD, University of Southern California
ClinicalTrials.gov Identifier: NCT01270542     History of Changes
Other Study ID Numbers: USC-HS-09-00068
Study First Received: December 1, 2010
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
Traction Retinal Detachment (PDR)
Proliferative Diabetic Retinopathy (PDR)

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Detachment
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014