Bevacizumab Against Recurrent Retinal Detachment

Bevacizumab Against Recurrent Retinal Detachment

Sponsors

Lead Sponsor: University of Wisconsin, Madison

Source University of Wisconsin, Madison
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.

Overall Status Active, not recruiting
Start Date January 21, 2015
Completion Date November 15, 2020
Primary Completion Date November 11, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete success of primary vitrectomy surgery 6 months
Secondary Outcome
Measure Time Frame
Presence of proliferative vitreoretinopathy 6 months
Enrollment 101
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bevacizumab

Arm Group Label: Bevacizumab

Other Name: Avastin

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michael Altaweel, MD Principal Investigator University of Wisconsin, Madison
Location
Facility: University of Wisconsin
Location Countries

United States

Verification Date

December 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Bevacizumab

Type: Experimental

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.

Label: Chart review

Type: No Intervention

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.

Acronym BEARRD
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov