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

NCT02834559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2022-04-05

No results posted yet for this study

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.

Conditions

  • Rhegmatogenous Retinal Detachment
  • High-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).

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • The Clinical Trials Centre Cologne

    collaborator OTHER

  • Pharmacy of the University Hospital Erlangen

    collaborator UNKNOWN

  • Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)

    collaborator UNKNOWN

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • Friederike Schaub, PD. Dr. · Department of Ophthalmology, University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-27
Primary Completion
2020-06-15
Completion
2020-06-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834559 on ClinicalTrials.gov