Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

October 27, 2016

Primary Completion Date

June 15, 2020

Study Completion Date

June 15, 2020

Conditions
Rhegmatogenous Retinal DetachmentHigh-risk for Proliferative Vitreoretinopathy (PVR)
Interventions
DRUG

5-fluorouracil and low molecular weight heparin

Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV).

DRUG

Placebo

Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV).

Trial Locations (13)

20246

Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf, Hamburg

40255

Universitäts-Augenklinik Düsseldorf, Düsseldorf

48145

Augenärzte am St. Franziskushospital Münster Augenklinik, Münster

50931

Augenklinik der Universität zu Köln, Cologne

53127

Augenklinik Uniklinik Bonn, Bonn

66280

Knappschaftskrankenhaus Sulzbach Augenklinik Sulzbach, Sulzbach

72076

STZ eyetrial am Department für Augenheilkunde, Tübingen

79106

Augenklinik Uniklinik Freiburg, Freiburg im Breisgau

04103

Uniklinik Leipzig Klinik und Poliklinik für Augenheilkunde, Leipzig

Unknown

Universitätsaugenklinik Göttingen, Göttingen

Universitätsaugenklinik Kiel, Kiel

Augenklinik TU München, München

Universitätsaugenklinik Regensburg, Regensburg

Sponsors
All Listed Sponsors
collaborator

German Research Foundation

OTHER

collaborator

The Clinical Trials Centre Cologne

OTHER

collaborator

Pharmacy of the University Hospital Erlangen

UNKNOWN

collaborator

Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)

UNKNOWN

lead

Universitätsklinikum Köln

OTHER