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Rhegmatogenous Retinal DetachmentPhase 3PRIVENTNCT02834559

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

A Phase 3 study testing 5-fluorouracil and low molecular weight heparin in people with Rhegmatogenous Retinal Detachment and High-risk for Proliferative Vitreoretinopathy (PVR), run by Universitätsklinikum Köln at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
5-fluorouracil and low molecular weight heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
326 participants
Where
13 sitesGermany
Study dates
27 Oct 2016to 15 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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)
  • Previous intraocular surgery except uncomplicated cataract surgery with posterior chamber lens implantation in study eye
  • Cataract surgery in study eye ≤ 3 months ago
  • Previous retinal procedures (laserpexy, cryopexy, intravitreal gas-injection, anti-VEGF or corticosteroid-injection) in study eye ≤ 6 months
  • Other uncontrolled ophthalmologic disorders
  • Single eyed patients (BCVA of fellow eye > 1.0 log MAR, < 0.1 decimal, < 1/10 tenth, or < 6/60 Snellen fraction [m])
  • Evidence or history of alcohol, medication or drug dependency within the last 12 months.
  • Evidence or history (within the last 12 months) of neurotic personality, psychiatric illness that requires or required treatment, epilepsy or suicide risk.
  • Systemic disorders not compatible with adjuvant application of 5-FU and LMWH via intraocular infusion, or not compatible with the local or general anesthesia
  • Any therapy with immunosuppressant or chemotherapy ≤ 3 months and during the trial period
  • Participation in another trial of IMPs or devices parallel to, or less than 3 months before screening, or previous participation in this trial.
  • Known to or suspected of not being able to comply with the protocol.
  • Inability to understand the rationale of this trial or the study aim
  • 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.
  • Positive urine pregnancy test, pregnancy or breastfeeding mother.
  • 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).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Augenklinik Uniklinik Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Augenklinik der Universität zu Köln

    Cologne, North Rhine-Westphalia, 50931

  • Universitäts-Augenklinik Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40255

  • Augenklinik Uniklinik Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitätsaugenklinik Göttingen

    Göttingen

  • Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Universitätsaugenklinik Kiel

    Kiel

  • Uniklinik Leipzig Klinik und Poliklinik für Augenheilkunde

    Leipzig, Saxony, 04103

  • Augenklinik TU München

    München

  • Augenärzte am St. Franziskushospital Münster Augenklinik

    Münster, North Rhine-Westphalia, 48145

  • Universitätsaugenklinik Regensburg

    Regensburg

  • Knappschaftskrankenhaus Sulzbach Augenklinik Sulzbach

    Sulzbach, Saarbrücken, 66280

  • STZ eyetrial am Department für Augenheilkunde

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

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.

Read the 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.

Being tested
5-fluorouracil and low molecular weight heparin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-fluorouracil and low molecular weight heparinDrug

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

  • PlaceboDrug

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

Study groups in NCT02834559
Study groupRoleWhat they receive
Adjuvant therapy with 5-FU and LMWHActive comparatorIntraoperative 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).
Receives: Drug: 5-fluorouracil and low molecular weight heparin
Standard of carePlacebo comparatorRoutinely 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).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: within 12 weeks

Secondary outcomes (8)

  1. PVR grade CP 1 or higher [yes/no]

    Measured: within 6 weeks

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

    Measured: within 6 weeks and 12 weeks

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

    Measured: within 6 weeks and 12 weeks

  4. Best Corrected Visual Acuity (BCVA) measured by ETDRS charts

    Measured: within 6 weeks and 12 weeks

  5. Retinal reattachment after primary intervention [yes/no]

    Measured: within 6 weeks and 12 weeks

  6. Number of retinal re-detachments and if present due to PVR [yes/no]

    Measured: within 6 weeks and 12 weeks

  7. Number and extent of surgical procedures necessary to achieve retinal reattachment

    Measured: within 12 weeks

  8. Occurrence of at least one drug-related adverse event that affects the study eye [yes/no]

    Measured: within 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2016 (estimated)
  2. Study start27 Oct 2016
  3. Primary completion15 Jun 2020
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02834559
Sponsor's protocol ID
uni-koeln-1782
Other IDs
2015-004731-12, 2015
Acronym
PRIVENT
Status last verified
Apr 2022
First submitted
12 Jul 2016
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30012187

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-fluorouracil and low molecular weight heparin in people with Rhegmatogenous Retinal Detachment and High-risk for Proliferative Vitreoretinopathy (PVR), run by Universitätsklinikum Köln at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no] (time frame: within 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02834559, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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