CompletedPhase 3

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

Germany326 participantsStarted 2016-10-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Primary rhegmatogenous retinal detachment (\< 4 weeks) in study eye
✓. Scheduled for pars plana vitrectomy for retinal detachment repair without combined cataract surgery in study eye
✓. Elevated protein levels in anterior chamber fluid (laser-flare value ≥ 15.0 pc/ms) in study eye
✓. Female or male patient ≥ 18 years of age
✓. Written informed consent

Exclusion criteria

✕. Retinal detachment lasting \> 4 weeks in study eye
✕. Traumatic retinal detachment in study eye
✕. Giant retinal tears in study eye (size \> 3 clock hours)
✕. Visual pre-existing PVR grade C in study eye
✕. Retinal dystrophies in study eye
✕. Scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in study eye
✕. Chronic inflammatory conditions in study eye
✕. Active retinal vascular disease in study eye

What they're measuring

Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]

Timeframe: within 12 weeks

Trial details

NCT IDNCT02834559

SponsorUniversitätsklinikum Köln

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-15

View on ClinicalTrials.gov More Rhegmatogenous Retinal Detachment trials