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

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

Sponsors

Lead Sponsor: Wills Eye

Source Wills Eye
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.

Overall Status Completed
Start Date June 2013
Completion Date November 2014
Primary Completion Date November 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease) up to 6 months
Secondary Outcome
Measure Time Frame
The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease) 6 months
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bevacizumab

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.

Arm Group Label: Bevacizumab

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jason Hsu, MD Principal Investigator WillsEye Hospital
Location
Facility: Mid Atlantic Retina- Wills Eye Institute
Location Countries

United States

Verification Date

March 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Wills Eye

Investigator Full Name: Jason Hsu, MD

Investigator Title: Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Bevacizumab

Type: Experimental

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)

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Outcomes were compared to a retrospective, historical control group.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov