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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Ozurdex® (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial

Authors: Philip J Banerjee, Catey Bunce, David G Charteris

Published in: Trials | Issue 1/2013

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Abstract

Background

Proliferative vitreoretinopathy (PVR) is the commonest cause of late anatomical failure in rhegmatogenous retinal detachment. Visual and anatomical outcomes remain poor despite advances in vitreoretinal surgical techniques with reported primary failure rates of up to nearly 50%. Numerous adjunctive medications have been evaluated in clinical trials with no agent gaining widespread acceptance and use.
This study was designed to investigate the benefits of using a slow-release dexamethasone implant delivered intra-operatively in patients undergoing vitrectomy surgery for retinal detachment with established PVR.

Methods/design

For the study, 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR will be randomised to receive either standard treatment or study treatment in a 1:1 treatment allocation ratio. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine peri-operative treatment and care, differing only in the addition of the supplementary adjunctive agent in the treatment group. The investigated primary outcome measure is stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months.

Discussion

This is the first randomised controlled clinical trial to investigate the use of an adjunctive slow-release dexamethasone implant in patients undergoing vitrectomy surgery for retinal detachments with proliferative vitreoretinopathy.

Trial registration

EudraCT No:2011-004498-96.
Appendix
Available only for authorised users
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Metadata
Title
Ozurdex® (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial
Authors
Philip J Banerjee
Catey Bunce
David G Charteris
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-358

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