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

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ClinicalTrials.gov Identifier: NCT02834559
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
German Research Foundation
The Clinical Trials Centre Cologne
Pharmacy of the University Hospital Erlangen
Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)
Information provided by (Responsible Party):
Universitätsklinikum Köln

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.


Condition or disease Intervention/treatment Phase
Rhegmatogenous Retinal Detachment High-risk for Proliferative Vitreoretinopathy (PVR) Drug: 5-fluorouracil and low molecular weight heparin Drug: Placebo Phase 3

Detailed Description:

Proliferative vitreoretinopathy (PVR) is a common cause for postoperative failure after vitreoretinal surgery for primary RRD. There is no standard-therapy to prevent PVR. Several attempts using chemotherapeutic agents have been undertaken to prevent this proliferation-process, but none of these was introduced into routine clinical practice.

Until recently, it has been challenging to identify patients with high risk for postoperative PVR formation. This is especially important, because in this trial treatment with the trial drug will be restricted to patients at high risk for PVR only.

Patients are assigned to the following treatment arms (1:1):

(A) 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).

Versus:

(B) Routinely used intraocular infusion with balanced salt solution (BSS) during routine PPV.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.
Study Start Date : October 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Adjuvant therapy with 5-FU and LMWH
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
Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV).

Placebo Comparator: Standard of care
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
Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV).




Primary Outcome Measures :
  1. Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no] [ Time Frame: within 12 weeks ]

Secondary Outcome Measures :
  1. PVR grade CP 1 or higher [yes/no] [ Time Frame: within 6 weeks ]
  2. PVR grade CA (anterior - full thickness retinal folds in clock hours) 1 or higher [yes/no] [ Time Frame: within 6 weeks and 12 weeks ]
  3. Degree of PVR (PVR grade CA 1-12, PVR grade CP 1-12 (in clock hours)) [ Time Frame: within 6 weeks and 12 weeks ]
  4. Best Corrected Visual Acuity (BCVA) measured by ETDRS charts [ Time Frame: within 6 weeks and 12 weeks ]
  5. Retinal reattachment after primary intervention [yes/no] [ Time Frame: within 6 weeks and 12 weeks ]
  6. Number of retinal re-detachments and if present due to PVR [yes/no] [ Time Frame: within 6 weeks and 12 weeks ]
  7. Number and extent of surgical procedures necessary to achieve retinal reattachment [ Time Frame: within 12 weeks ]
  8. Occurrence of at least one drug-related adverse event that affects the study eye [yes/no] [ Time Frame: within 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Retinal detachment lasting > 4 weeks in study eye
  2. Traumatic retinal detachment in study eye
  3. Giant retinal tears in study eye (size > 3 clock hours)
  4. Visual pre-existing PVR grade C in study eye
  5. Retinal dystrophies in study eye
  6. Scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in study eye
  7. Chronic inflammatory conditions in study eye
  8. Active retinal vascular disease in study eye
  9. Proliferative diabetic retinopathy in study eye
  10. Manifest uveitis in study eye
  11. Endophthalmitis in study eye
  12. Perforating and non-perforating trauma in study eye
  13. Malignant intraocular tumor in study eye
  14. Aphakia in study eye
  15. Uncontrolled glaucoma or ocular hypertension in study eye (intraocular pressure ≥ 30 mmHg despite IOP lowering therapy)
  16. Previous intraocular surgery except uncomplicated cataract surgery with posterior chamber lens implantation in study eye
  17. Cataract surgery in study eye ≤ 3 months ago
  18. Previous retinal procedures (laserpexy, cryopexy, intravitreal gas-injection, anti-VEGF or corticosteroid-injection) in study eye ≤ 6 months
  19. Other uncontrolled ophthalmologic disorders
  20. Single eyed patients (BCVA of fellow eye > 1.0 log MAR, < 0.1 decimal, < 1/10 tenth, or < 6/60 Snellen fraction [m])
  21. Evidence or history of alcohol, medication or drug dependency within the last 12 months.
  22. Evidence or history (within the last 12 months) of neurotic personality, psychiatric illness that requires or required treatment, epilepsy or suicide risk.
  23. Systemic disorders not compatible with adjuvant application of 5-FU and LMWH via intraocular infusion, or not compatible with the local or general anesthesia
  24. Any therapy with immunosuppressant or chemotherapy ≤ 3 months and during the trial period
  25. Participation in another trial of IMPs or devices parallel to, or less than 3 months before screening, or previous participation in this trial.
  26. Known to or suspected of not being able to comply with the protocol.
  27. Inability to understand the rationale of this trial or the study aim
  28. Any dependency of the patient to the Investigator or the trial site, e.g. employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial site, as well as family members of the employees or the Investigator.
  29. Positive urine pregnancy test, pregnancy or breastfeeding mother.
  30. Women of child bearing potential without satisfactory contraception, i.e. hormonal contraceptives for at least 14 days before trial enrolment, IUD, double barrier (women of child bearing age must be counselled about the use of adequate contraception).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834559


Contacts
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Contact: Friederike Schaub, PD Dr. 004922147886041 friederike.schaub@uk-koeln.de

Locations
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Germany
Augenklinik Uniklinik Freiburg Recruiting
Freiburg, BW, Germany, 79106
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Hansjürgen Agostini, MD         
Sub-Investigator: Fanni Molnár, MD         
STZ eyetrial am Department für Augenheilkunde Recruiting
Tübingen, BW, Germany, 72076
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Karl Ulrich Bartz-Schmidt, MD         
Sub-Investigator: Michael Partsch, MD         
Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf Recruiting
Hamburg, HH, Germany, 20246
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Augenklinik Uniklinik Bonn Recruiting
Bonn, NRW, Germany, 53127
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Frank Holz, MD         
Sub-Investigator: Monica Fleckenstein, MD         
Universitäts-Augenklinik Düsseldorf Recruiting
Dusseldorf, NRW, Germany, 40255
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Rainer Guthoff, MD         
Sub-Investigator: Stefan Schrader, MD         
Augenklinik der Universität zu Köln Recruiting
Koln, NRW, Germany, 50931
Contact: Friederike Schaub, MD    0049 221 478 86041    friederike.schaub@uk-koeln.de   
Contact: Bernd Kirchhof, MD    0049 221 478 4105    bernd.kirchhof@uk-koeln.de   
Principal Investigator: Bernd Kirchhof, MD         
Sub-Investigator: Manuel Hermann, MD         
Sub-Investigator: Claudia Dahlke, MD         
Sub-Investigator: Philipp Müther, MD         
Sub-Investigator: Alexandra Lappas, MD         
Augenärzte am St. Franziskushospital Münster Augenklinik Recruiting
Munster, NRW, Germany, 48145
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Albrecht Lommatzsch, MD         
Sub-Investigator: Matthias Gutfleisch, MD         
Knappschaftskrankenhaus Sulzbach Augenklinik Sulzbach Recruiting
Sulzbach, Saarbrücken, Germany, 66280
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Karl Boden, MD         
Sub-Investigator: Kai Januschowski, MD         
Uniklinik Leipzig Klinik und Poliklinik für Augenheilkunde Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Friederike Schaub, MD    0049-221-478-86041    friederike.schaub@uk-koeln.de   
Principal Investigator: Peter Wiedemann, MD         
Sub-Investigator: Claudia Jochmann, MD         
Universitätsaugenklinik Göttingen Recruiting
Göttingen, Germany
Contact       friederike.schaub@uk-koeln.de   
Principal Investigator: Nicolas Feltgen, Prof. Dr.         
Sub-Investigator: Hans Hoerauf, Prof. Dr.         
Universitätsaugenklinik Kiel Recruiting
Kiel, Germany
Contact       friederike.schaub@uk-koeln.de   
Principal Investigator: Johann Roider, Prof. Dr.         
Sub-Investigator: Felix Treumer, PD Dr.         
Augenklinik TU München Recruiting
München, Germany
Contact       friederike.schaub@uk-koeln.de   
Principal Investigator: Chris Lohmann, Prof. Dr.         
Sub-Investigator: Mathias Maier, Prof. Dr.         
Universitätsaugenklinik Regensburg Recruiting
Regensburg, Germany
Contact       friederike.schaub@uk-koeln.de   
Principal Investigator: Andreea Gamuslescu, PD Dr.         
Sub-Investigator: Horst Helbig, Prof. Dr.         
Sponsors and Collaborators
Universitätsklinikum Köln
German Research Foundation
The Clinical Trials Centre Cologne
Pharmacy of the University Hospital Erlangen
Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)
Investigators
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Principal Investigator: Bernd Kirchhof, Prof. Dr. Department of Ophthalmology, University of Cologne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT02834559     History of Changes
Other Study ID Numbers: uni-koeln-1782
2015-004731-12 ( EudraCT Number )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Retinal Detachment
Vitreoretinopathy, Proliferative
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Fluorouracil
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents