This study investigates the effectiveness of a simple treatment to prevent proliferative vitreoretinopathy (PVR). Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug.
Proliferative vitreoretinopathy (PVR) is a common cause for postoperative failure after vitreoretinal surgery for primary RRD. There is no standard-therapy to prevent PVR. Several attempts using chemotherapeutic agents have been undertaken to prevent this proliferation-process, but none of these was introduced into routine clinical practice. Until recently, it has been challenging to identify patients with high risk for postoperative PVR formation. This is especially important, because in this trial treatment with the trial drug will be restricted to patients at high risk for PVR only. Patients are assigned to the following treatment arms (1:1): (A) Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV) in high-risk patients for proliferative vitreoretinopathy (PVR) with primary rhegmatogenous retinal detachment (RRD). Versus: (B) Routinely used intraocular infusion with balanced salt solution (BSS) during routine PPV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
326
Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV).
Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV).
Augenklinik Uniklinik Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
STZ eyetrial am Department für Augenheilkunde
Tübingen, Baden-Wurttemberg, Germany
Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf
Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]
Time frame: within 12 weeks
PVR grade CP 1 or higher [yes/no]
Time frame: within 6 weeks
PVR grade CA (anterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]
Time frame: within 6 weeks and 12 weeks
Degree of PVR (PVR grade CA 1-12, PVR grade CP 1-12 (in clock hours))
Time frame: within 6 weeks and 12 weeks
Best Corrected Visual Acuity (BCVA) measured by ETDRS charts
Time frame: within 6 weeks and 12 weeks
Retinal reattachment after primary intervention [yes/no]
Time frame: within 6 weeks and 12 weeks
Number of retinal re-detachments and if present due to PVR [yes/no]
Time frame: within 6 weeks and 12 weeks
Number and extent of surgical procedures necessary to achieve retinal reattachment
Time frame: within 12 weeks
Occurrence of at least one drug-related adverse event that affects the study eye [yes/no]
Time frame: within 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hamburg, Hamburg, Germany
Augenklinik Uniklinik Bonn
Bonn, North Rhine-Westphalia, Germany
Augenklinik der Universität zu Köln
Cologne, North Rhine-Westphalia, Germany
Universitäts-Augenklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Augenärzte am St. Franziskushospital Münster Augenklinik
Münster, North Rhine-Westphalia, Germany
Knappschaftskrankenhaus Sulzbach Augenklinik Sulzbach
Sulzbach, Saarbrücken, Germany
Uniklinik Leipzig Klinik und Poliklinik für Augenheilkunde
Leipzig, Saxony, Germany
Universitätsaugenklinik Göttingen
Göttingen, Germany
...and 3 more locations