Eye Injections of Bevacizumab to See if Medication Helps to Lower Risk of Scar Tissue Development in the Retina and Repeated Retinal Detachment.

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
First received: May 20, 2013
Last updated: September 30, 2014
Last verified: September 2014
The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on the rates of recurrent retinal detachment and scar tissue formation.

Condition Intervention
Retinal Detachment
Vitreoretinopathy Proliferative
Drug: Bevacizumab

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy

Resource links provided by NLM:

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • The effect of intravitreal bevacizumab injections on retinal detachment rate (increase or decrease) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.

Secondary Outcome Measures:
  • The effect of intravitreal bevacizumab injections on the development of recurrent Proliferative vitreoretinopathy (PVR). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of recurrent PVR .

Other Outcome Measures:
  • Intravitreal bevacizumab injections impact on visual acuity score (change in letters read). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Drug: Bevacizumab
.005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Other Names:
  • Avastin
  • intravitreal injection


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

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Undergoing pars plana vitrectomy with or without scleral buckling for recurrent RD due to PVR with planned silicone oil instillation.

Exclusion Criteria:

  • Prior anti-VEGF (vascular endothelial growth factor) injections within 3 months of retinal detachment surgery.
  • Traction retinal detachment due to proliferative diabetic retinopathy.
  • Inability to flatten retina completely intraoperatively
  • Known allergy or contraindication to intravitreal bevacizumab
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01860586

United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Principal Investigator: Jason Hsu, MD WillsEye Hospital
  More Information

Responsible Party: Brian Burke, MPH, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01860586     History of Changes
Other Study ID Numbers: HsuPVR13  MARPVR2013 
Study First Received: May 20, 2013
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Proliferative Vitreoretinopathy
retinal detachment

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Vitreoretinopathy, Proliferative
Eye Diseases
Mental Disorders
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016