Universität zu Köln

Schaub, Friederike, Hoerster, Robert, Schiller, Petra, Felsch, Moritz, Kraus, Daria, Zarrouk, Marouan ORCID: 0000-0002-3259-6123, Kirchhof, Bernd and Fauser, Sascha (2018). Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial. Trials, 19. LONDON: BMC. ISSN 1745-6215

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Abstract

Background: Proliferative vitreoretinopathy (PVR) is the major cause for postoperative failure after vitreo-retinal surgery for primary rhegmatogenous retinal detachment (RRD). Adjunct pharmaceutical therapy was found to be ineffective once PVR is established. Preliminary data suggest that prevention of PVR yields better functional outcome. So far, there is no standard therapy to prevent PVR. Methods/design: This is a randomized, double-blind, controlled, multicenter, interventional trial with one interim analysis. High-risk patients for PVR with primary RRD will be allocated equally to the following treatment arms: (a) verum: intraoperative adjuvant application of 5-fluorouracil (5-FU) and low-molecular-weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV) and (b) placebo: routinely used intraocular infusion with balanced salt solution during routine PPV. PVR risk is assessed by non-invasive aqueous flare measurement by using laser flare photometry. The primary endpoint of the trial is the occurrence of PVR grade CP (C: full-thickness retinal folds or subretinal strands in clock hours; P: located posterior to equator) 1 or higher within 12 weeks after treatment. Secondary endpoints include PVR grade CA (A: located anterior to equator), best corrected visual acuity, number and extent of surgical procedures to achieve retinal re-attachment, and occurrence of drug-related adverse events within 12 weeks. It is assumed, on the basis of previously published results, that the incidence of PVR grade CP 1 is 35% in the control group and that a reduction by one third would be clinically relevant. Given the sequential design and adjustment for a dropout rate of 5%, a total sample size of 560 patients (280 per group) was calculated to ensure a power of 80% for the confirmatory analysis. Discussion: The present trial uses intraoperative intravitreal 5-FU and LMWH as a prophylactic therapy in high-risk patients with primary RRD, aiming to reduce the incidence of PVR in the group that receives the trial drug. Using laser flare photometry to identify high-risk patients for PVR, this trial will test the effectiveness of a simple treatment to prevent PVR.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schaub, Friederike UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoerster, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Schiller, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Felsch, Moritz UNSPECIFIED UNSPECIFIED UNSPECIFIED Kraus, Daria UNSPECIFIED UNSPECIFIED UNSPECIFIED Zarrouk, Marouan UNSPECIFIED orcid.org/0000-0002-3259-6123 UNSPECIFIED Kirchhof, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Fauser, Sascha UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-179697
DOI:	10.1186/s13063-018-2761-x
Journal or Publication Title:	Trials
Volume:	19
Date:	2018
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MOLECULAR-WEIGHT HEPARIN; AQUEOUS FLARE; EXTERNAL VALIDATION; CLINICAL-TRIAL; CLASSIFICATION; MANAGEMENT; SURGERY; PREDICT; TABLES; CELLS Multiple languages Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17969