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Bevacizumab Against Recurrent Retinal Detachment (BEARRD)

Primary Purpose

Retinal Detachment, Proliferative Vitreoretinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retinal Detachment focused on measuring Retinal detachment, Proliferative vitreoretinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Eyes with rhegmatogenous retinal detachment

Exclusion Criteria:

  • Presence of PVR
  • Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
  • Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
  • Secondary retinal detachment repair
  • Use of silicone oil as tamponade agent
  • Patients less than 18 years of age
  • Pregnancy
  • Known allergy or contraindication to intravitreal bevacizumab

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bevacizumab

Chart review

Arm Description

Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.

Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.

Outcomes

Primary Outcome Measures

Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.

Secondary Outcome Measures

Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy

Full Information

First Posted
July 15, 2014
Last Updated
March 1, 2021
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02192970
Brief Title
Bevacizumab Against Recurrent Retinal Detachment
Acronym
BEARRD
Official Title
Bevacizumab Against Recurrent Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Proliferative Vitreoretinopathy
Keywords
Retinal detachment, Proliferative vitreoretinopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Arm Title
Chart review
Arm Type
No Intervention
Arm Description
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Primary Outcome Measure Information:
Title
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
Description
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Eyes with rhegmatogenous retinal detachment Exclusion Criteria: Presence of PVR Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy. Recent intravitreal injection of an anti-VEGF agent less than 3 months prior Secondary retinal detachment repair Use of silicone oil as tamponade agent Patients less than 18 years of age Pregnancy Known allergy or contraindication to intravitreal bevacizumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Altaweel, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23582767
Citation
Pennock S, Kim D, Mukai S, Kuhnle M, Chun DW, Matsubara J, Cui J, Ma P, Maberley D, Samad A, Van Geest RJ, Oberstein SL, Schlingemann RO, Kazlauskas A. Ranibizumab is a potential prophylaxis for proliferative vitreoretinopathy, a nonangiogenic blinding disease. Am J Pathol. 2013 May;182(5):1659-70. doi: 10.1016/j.ajpath.2013.01.052. Epub 2013 Apr 9.
Results Reference
background
Links:
URL
http://pubmed.gov
Description
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Bevacizumab Against Recurrent Retinal Detachment

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