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

Primary Purpose

Retinal Detachment, Vitreoretinopathy Proliferative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring pvr, rd, Proliferative Vitreoretinopathy, retinal detachment, detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mid Atlantic Retina- Wills Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

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)

Outcomes

Primary Outcome Measures

The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)
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

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

Full Information

First Posted
May 20, 2013
Last Updated
March 3, 2017
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT01860586
Brief Title
Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment.
Official Title
A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Vitreoretinopathy Proliferative
Keywords
pvr, rd, Proliferative Vitreoretinopathy, retinal detachment, detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Outcomes were compared to a retrospective, historical control group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin, Intrasilicone oil intravitreal injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)
Description
To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).
Description
Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Organizational Affiliation
WillsEye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina- Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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