Overview
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2020-06-01
2020-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Universitätsklinikum KölnCollaborators:
German Research Foundation
Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)
Pharmacy of the University Hospital Erlangen
The Clinical Trials Centre CologneTreatments:
Calcium heparin
Dalteparin
Fluorouracil
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
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).