Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment.

Not Applicable

Completed

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

• Registration Number: NCT01860586
• Lead Sponsor: Wills Eye

Brief Summary

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.

Detailed Description

Proliferative vitreoretinopathy (PVR) remains the most significant obstacle to successful retinal detachment (RD) repair, accounting for up to 75% of all primary surgical failures. Characterized by the proliferation of cells on the preretinal or subretinal surface, PVR ultimately leads to contraction, foreshortening, and ultimately recurrent detachment of the retina. Several PVR risk factors have been identified, including pre-existing uveitis, large retinal tears, multiple retinal breaks, detachments involving greater than two quadrants of the retina, vitreous hemorrhage, and choroidal detachment. Given the absence of a proven medical therapy for PVR and prior studies establishing VEGF as a potential therapeutic target, further clinical evaluation is warranted. Herein, we report outcomes of a prospective, non-randomized, historical-control pilot study evaluating the effect of serial intrasilicone oil bevacizumab injections on outcomes of PVR-related RD repair.

Study Timeline

• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Study Start: 2013-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-03
• Results First Submitted: 2017-03-03
• Results First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	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)

Primary Outcome Measures

Name	Time	Method
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)	up to 6 months	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

Name	Time	Method
The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)	6 months	To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .

Trial Locations

Locations (1)

Mid Atlantic Retina- Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States