Universität zu Köln

Schaub, Friederike ORCID: 0000-0003-2648-1626, Schiller, Petra ORCID: 0000-0002-9957-1465, Hoerster, Robert, Kraus, Daria, Holz, Frank G., Guthoff, Rainer, Agostini, Hansjurgen, Spitzer, Martin S., Wiedemann, Peter, Lommatzsch, Albrecht, Boden, Karl T., Dimopoulos, Spyridon, Bemme, Sebastian, Tamm, Svenja, Maier, Mathias, Roider, Johann, Enders, Philip, Altay, Lebriz, Fauser, Sascha and Kirchhof, Bernd (2022). Intravitreal 5-Fluorouracil and Heparin to Prevent Proliferative Vitreoretinopathy Results from a Randomized Clinical Trial. Ophthalmology, 129 (10). S. 1129 - 1142. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1549-4713

Full text not available from this repository.

Abstract

Purpose: Proliferative vitreoretinopathy (PVR) is the major cause for surgical failure after primary rhegmatogenous retinal detachment (RRD). So far, no therapy has been proven to prevent PVR. Promising results for 5-fluorouracil (5-FU) and low-molecular weight heparin (LMWH) in high-risk eyes have been reported previously. The objective of this trial was to examine the effect of adjuvant intravitreal therapy with 5-FU and LMWH compared with placebo on incidence of PVR in high-risk patients with primary RRD. Design: Randomized, double-blind, controlled, multicenter, interventional trial with 1 interim analysis. Participants: Patients with RRD who were considered to be at high risk for PVR were included. Risk of PVR was assessed by noninvasive aqueous flare measurement using laser flare photometry. Methods: Patients were randomized 1:1 to verum (200 mg/ml 5-FU and 5 IU/ml dalteparin) and placebo (balanced salt solution) intravitreally applied during routine pars plana vitrectomy. Main Outcome Measures: Primary end point was the development of PVR grade CP (full-thickness retinal folds or subretinal strands in clock hours located posterior to equator) 1 or higher within 12 weeks after surgery. For grading, an end point committee assessed fundus photographs. Secondary end points included bestcorrected visual acuity and redetachment rate. A group sequential design with 1 interim analysis was applied using the O'Brien and Fleming boundaries. Proliferative vitreoretinopathy grade CP incidence was compared using a Mantel-Haenszel test stratified by surgeon. Results: A total of 325 patients in 13 German trial sites had been randomized (verum, n = 163; placebo, n = 162). In study eyes, mean laser flare was 31 +/- 26 pc/ms. No significant difference was found in PVR rate. Primary analysis in the modified intention-to-treat population results were: verum 28% vs. placebo 23% (including not assessable cases as failures); odds ratio [OR], 1.25; 95% confidence interval [CI], 0.76-2.08; P = 0.77. Those in the per-protocol population were: 12% vs. 12%; OR, 1.05; 95% CI, 0.47-2.34; P = 0.47. None of the secondary end points showed any significant difference between treatment groups. During the study period, no relevant safety risks were identified. Conclusions: Rate of PVR did not differ between adjuvant therapy with 5-FU and LMWH and placebo treatment in eyes with RRD. (C) 2022 by the American Academy of Ophthalmology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schaub, Friederike UNSPECIFIED orcid.org/0000-0003-2648-1626 UNSPECIFIED Schiller, Petra UNSPECIFIED orcid.org/0000-0002-9957-1465 UNSPECIFIED Hoerster, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Kraus, Daria UNSPECIFIED UNSPECIFIED UNSPECIFIED Holz, Frank G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Guthoff, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Agostini, Hansjurgen UNSPECIFIED UNSPECIFIED UNSPECIFIED Spitzer, Martin S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiedemann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Lommatzsch, Albrecht UNSPECIFIED UNSPECIFIED UNSPECIFIED Boden, Karl T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dimopoulos, Spyridon UNSPECIFIED UNSPECIFIED UNSPECIFIED Bemme, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Tamm, Svenja UNSPECIFIED UNSPECIFIED UNSPECIFIED Maier, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Roider, Johann UNSPECIFIED UNSPECIFIED UNSPECIFIED Enders, Philip UNSPECIFIED UNSPECIFIED UNSPECIFIED Altay, Lebriz UNSPECIFIED UNSPECIFIED UNSPECIFIED Fauser, Sascha UNSPECIFIED UNSPECIFIED UNSPECIFIED Kirchhof, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-694834
DOI:	10.1016/j.ophtha.2022.05.024
Journal or Publication Title:	Ophthalmology
Volume:	129
Number:	10
Page Range:	S. 1129 - 1142
Date:	2022
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1549-4713
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language AQUEOUS-HUMOR FLARE; RETINAL DETACHMENTS; RISK-FACTORS; VITRECTOMY; REPRODUCIBILITY; INFLAMMATION; MANAGEMENT; VALIDITY; METER Multiple languages Ophthalmology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69483