Bevacizumab Against Recurrent Retinal Detachment

Phase 2

Completed

• Conditions: Retinal Detachment; Proliferative Vitreoretinopathy
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02192970
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Study Start: 2015-01-21
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2021-03
• Results First Submitted: 2021-03-01
• Results First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Results First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age ≥ 18 years
• Eyes with rhegmatogenous retinal detachment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery	6 months	Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.

Secondary Outcome Measures

Name	Time	Method
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy	6 months

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States