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

March 3, 2017 updated by: Jason Hsu, MD, Wills Eye

A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina- Wills Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Drug: 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.
Other Names:
  • Avastin
  • Intrasilicone oil intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)
Time Frame: 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.
up to 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).
Time Frame: 6 months
Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Investigators

  • Principal Investigator: Jason Hsu, MD, WillsEye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (ESTIMATE)

May 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HsuPVR13
  • MARPVR2013 (OTHER: Mid Atlantic Retina)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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