Bevacizumab Against Recurrent Retinal Detachment

NCT ID: NCT02192970

Last Updated: 2021-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-21

Study Completion Date

2019-11-11

Brief Summary

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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

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Conditions

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Retinal Detachment Proliferative Vitreoretinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Chart review

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bevacizumab

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Altaweel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23582767 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://pubmed.gov

Related Info

Other Identifiers

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A536070

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/OPHTHAL&VIS SCI

Identifier Type: OTHER

Identifier Source: secondary_id

2014-0931

Identifier Type: -

Identifier Source: org_study_id

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