Intravitreal 5-Fluorouracil and Heparin to Prevent Proliferative Vitreoretinopathy

Schaub, Friederike

; Schiller, Petra

; Hoerster, Robert ; Kraus, Daria ; Holz, Frank G. ; Guthoff, Rainer ; Agostini, Hansjürgen ; 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 ; Kirchhof, Bernd ; Pfeiffer, Andrea ; Willms, Sandra ; Binder, Susanne ; Le Mer, Yannik ; Stützer, Hartmut ; Lemmen, Klaus-Dieter ; Heimke-Brinck, Ralph ; Borst, Tobias ; Bartz-Schmidt, Karl Ulrich ; Callizo, Josep ; Dahlke, Claudia ; Eberwein, Philipp ; Ehlken, Christoph ; Feltgen, Nicolas ; Gamulescu, Andreea ; Gelisken, Faik ; Gutfleisch, Matthias ; Haus, Arno ; Helbig, Horst ; Hermann, Manuel ; Januschowski, Kai ; Jochmann, Claudia ; Krohne, Tim ; Lagrèze, Wolf ; Lange, Clemens ; Lohmann, Chris ; Macek, Marc Andrej ; Märker, David ; Mayer, Christian ; Meier, Petra ; Müther, Philipp ; Prahs, Philipp ; Purtskhvanidze, Konstantine ; Rehak, Matus ; Schaub, Friederike ; Schick, Tina ; Schmitz-Valckenberg, Steffen ; Schultheiß, Maximilian ; Skevas, Christos ; Stahl, Andreas ; Szurman, Peter ; Unterlauft, Jan Darius ; Hellmich, Martin ; Kuhr, Katrin

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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

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