drugset / Trial / NCT02834559
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.
Phase 3
Completed
326 enrolled
University Hospital Cologne
German Research Foundation · collabInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE) · collabPharmacy of the University Hospital Erlangen · collabThe Clinical Trials Centre Cologne · collab
RandomizedSingle-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2016-10-27
- Primary completion
- 2020-06-15
- Completion
- 2020-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fluorouracil | Small molecule | — | Other |