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
Friederike SchaubSascha Fauser

Abstract

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. 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 ante...Continue Reading

References

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Citations

May 16, 2019·Acta Diabetologica·Matias IglickiUNKNOWN International Retina Group (IRG)
Jul 16, 2020·Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft·F SchaubS Fauser
Nov 19, 2020·Klinische Monatsblätter für Augenheilkunde·Friederike Schaub, Tina Schick

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Methods Mentioned

BETA
contraception
pregnancy tests

Clinical Trials Mentioned

NCT02834559

Software Mentioned

SAS
SPSS Statistics
PRIVENT
R
gsDesign
TEN

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