Eye Injections of Bevacizumab to See if Medication Helps to Lower Risk of Scar Tissue Development in the Retina and Repeated Retinal Detachment.
This study is currently recruiting participants.
Verified October 2013 by Wills Eye
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
First received: May 20, 2013
Last updated: October 14, 2013
Last verified: October 2013
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Wills Eye:
Primary Outcome Measures:
- The effect of intravitreal bevacizumab injections on retinal detachment rate (increase or decrease) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]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 recurrent Proliferative vitreoretinopathy (PVR). [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of recurrent PVR .
Other Outcome Measures:
- Intravitreal bevacizumab injections impact on visual acuity score (change in letters read). [ Time Frame: 6 months ] [ Designated as safety issue: No ]Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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)
.005 mL of Bevacizumab 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01860586
|Contact: Jessica Jordanfirstname.lastname@example.org|
|United States, Pennsylvania|
|Mid Atlantic Retina- Wills Eye Institute||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator: Jason Hsu, MD|
|Sub-Investigator: Sunir Garg, MD|
|Sub-Investigator: Marc Spirn, MD|
|Sub-Investigator: Richard Kaiser, MD|
|Sub-Investigator: Omesh Gupta, MD|
|Principal Investigator: Carl Park, MD|
|Sub-Investigator: Joseph Maguire, MD|
|Sub-Investigator: Carl Regillo, MD|
|Sub-Investigator: Allen Ho, MD|
|Sub-Investigator: Michael Dollin, MD|
|Sub-Investigator: Christopher Brady, MD|
|Sub-Investigator: John Pitcher, MD|
Sponsors and Collaborators
|Principal Investigator:||Jason Hsu, MD||WillsEye Hospital|