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 currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wills Eye
Sponsor:
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
NCT01860586
First received: May 20, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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: June 2014
Estimated Primary Completion Date: June 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

  Eligibility

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

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
  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: NCT01860586

Contacts
Contact: Jessica Jordan 215-928-3092 research@midatlanticretina.com

Locations
United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Jason Hsu, MD         
Sub-Investigator: Sunir Garg, MD         
Sub-Investigator: Marc Spirn, MD         
Sub-Investigator: Richard Kaiser, MD         
Sub-Investigator: Omesh Gupta, MD         
Principal Investigator: Carl Park, MD         
Sub-Investigator: Joseph Maguire, MD         
Sub-Investigator: Carl Regillo, MD         
Sub-Investigator: Allen Ho, MD         
Sub-Investigator: Michael Dollin, MD         
Sub-Investigator: Christopher Brady, MD         
Sub-Investigator: John Pitcher, MD         
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Jason Hsu, MD WillsEye Hospital
  More Information

No publications provided

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: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
pvr
rd
Proliferative Vitreoretinopathy
retinal detachment
detachment

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Vitreoretinopathy, Proliferative
Mental Disorders
Retinal Diseases
Eye 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 September 29, 2014