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Bevacizumab Against Recurrent Retinal Detachment (BEARRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192970
Recruitment Status : Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Proliferative Vitreoretinopathy Drug: Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : January 21, 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: 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.
Drug: Bevacizumab
Other Name: Avastin

No Intervention: 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.



Primary Outcome Measures :
  1. Complete success of primary vitrectomy surgery [ Time Frame: 6 months ]
    Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.


Secondary Outcome Measures :
  1. Presence of proliferative vitreoretinopathy [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192970


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Michael Altaweel, MD University of Wisconsin, Madison

Additional Information:
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02192970     History of Changes
Other Study ID Numbers: UW-BEARRD
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Retinal detachment
Proliferative vitreoretinopathy
Additional relevant MeSH terms:
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Retinal Detachment
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors