Status:
COMPLETED
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.
Lead Sponsor:
Universitätsklinikum Köln
Collaborating Sponsors:
German Research Foundation
The Clinical Trials Centre Cologne
Conditions:
Rhegmatogenous Retinal Detachment
High-risk for Proliferative Vitreoretinopathy (PVR)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (L...
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 chemo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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).
Key Trial Info
Start Date :
October 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT02834559
Start Date
October 27 2016
End Date
June 15 2020
Last Update
April 5 2022
Active Locations (13)
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1
Augenklinik Uniklinik Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
STZ eyetrial am Department für Augenheilkunde
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Klinik und Poliklinik für Augenheilkunde Uniklinik Hamburg Eppendorf
Hamburg, Hamburg, Germany, 20246
4
Augenklinik Uniklinik Bonn
Bonn, North Rhine-Westphalia, Germany, 53127