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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

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

NCT ID

NCT02192970

First Posted

July 15, 2014

Last Updated

March 1, 2021

Sponsor

University of Wisconsin, Madison

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

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

Arm Title

Chart review

Arm Type

No Intervention

Arm Description

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

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

Related Info

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Bevacizumab Against Recurrent Retinal Detachment

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