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

NCT02834559 | Completed Phase 3 DMC

• 2 other identifiers: uni-koeln-17822015-004731-12
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 13

Brief 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)

Outcome Measures

Primary Outcomes (1)

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

  within 12 weeks

Secondary Outcomes (8)

• PVR grade CP 1 or higher [yes/no]

  within 6 weeks

• PVR grade CA (anterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]

  within 6 weeks and 12 weeks

• Degree of PVR (PVR grade CA 1-12, PVR grade CP 1-12 (in clock hours))

  within 6 weeks and 12 weeks

• Best Corrected Visual Acuity (BCVA) measured by ETDRS charts

  within 6 weeks and 12 weeks

• Retinal reattachment after primary intervention [yes/no]

  within 6 weeks and 12 weeks

Study Arms (2)

Adjuvant therapy with 5-FU and LMWH

ACTIVE COMPARATOR

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).

Drug: 5-fluorouracil and low molecular weight heparin

Standard of care

PLACEBO COMPARATOR

Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV) in high-risk patients for proliferative vitreoretinopathy (PVR) with primary rhegmatogenous retinal detachment (RRD).

Drug: Placebo

Interventions

5-fluorouracil and low molecular weight heparin DRUG

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

Adjuvant therapy with 5-FU and LMWH

Placebo DRUG

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Proliferative diabetic retinopathy in study eye
• Manifest uveitis in study eye
• Endophthalmitis in study eye
• Perforating and non-perforating trauma in study eye
• Malignant intraocular tumor in study eye
• Aphakia in study eye
• Uncontrolled glaucoma or ocular hypertension in study eye (intraocular pressure ≥ 30 mmHg despite IOP lowering therapy)

Sponsors & Collaborators

• Universitätsklinikum Köln: lead
• German Research Foundation: collaborator
• The Clinical Trials Centre Cologne: collaborator
• Pharmacy of the University Hospital Erlangen: collaborator
• Institute of Medical Statistics, Informatics and Epidemiology (IMSIE): collaborator

Study Sites (13)

Augenklinik Uniklinik Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

STZ eyetrial am Department für Augenheilkunde

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Augenklinik Uniklinik Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Augenklinik der Universität zu Köln

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Universitäts-Augenklinik Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40255, Germany

Location

Augenärzte am St. Franziskushospital Münster Augenklinik

Münster, North Rhine-Westphalia, 48145, Germany

Location

Knappschaftskrankenhaus Sulzbach Augenklinik Sulzbach

Sulzbach, Saarbrücken, 66280, Germany

Location

Uniklinik Leipzig Klinik und Poliklinik für Augenheilkunde

Leipzig, Saxony, 04103, Germany

Location

Universitätsaugenklinik Göttingen

Göttingen, Germany

Location

Universitätsaugenklinik Kiel

Kiel, Germany

Location

Augenklinik TU München

München, Germany

Location

Universitätsaugenklinik Regensburg

Regensburg, Germany

Location

Related Publications (1)

• Schaub F, Hoerster R, Schiller P, Felsch M, Kraus D, Zarrouk M, Kirchhof B, Fauser S. Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial. Trials. 2018 Jul 16;19(1):384. doi: 10.1186/s13063-018-2761-x.

  PMID: 30012187 DERIVED

MeSH Terms

Interventions

Fluorouracil; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Friederike Schaub, PD. Dr.

  Department of Ophthalmology, University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 15, 2016
• Study Start: October 27, 2016
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

DE (13)