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Avastin for PDR (Proliferative Diabetic Retinopathy) (PDR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270542
First Posted: January 5, 2011
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Southern California
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 (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 Outcome Measures:
  • 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. ]
  • 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)


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01270542     History of Changes
Other Study ID Numbers: USC-HS-09-00068
First Submitted: December 1, 2010
First Posted: January 5, 2011
Results First Submitted: May 19, 2014
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017
Last Verified: May 2014

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

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
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
Growth Inhibitors
Antineoplastic Agents