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

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Köln
• Collaborators: German Research Foundation; Institute of Medical Statistics, Informatics and Epidemiology (IMSIE); Pharmacy of the University Hospital Erlangen; The Clinical Trials Centre Cologne
• Treatments: 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).