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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Retinal Detachment Vitreoretinopathy Proliferative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Outcomes were compared to a retrospective, historical control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.

Interventions

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Bevacizumab

Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.

Intervention Type DRUG

Other Intervention Names

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Avastin Intrasilicone oil intravitreal injection

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No