Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease).

It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Adults (male or female over 18) with Type 1 or Type 2 diabetes mellitus

2. Grade 2-4 fundus obscuring diabetic vitreous haemorrhage of at least 2 months duration prior to screening in the study eye.

3. Subjects who have elected to undergo a therapeutic pars plana vitrectomy to clear persistent diabetic vitreous haemorrhage

4. Best corrected visual acuity from 40 letters (using 4 metre ETDRS visual acuity score) to perception of light in the study eye

5. Patients able and willing to give written and witnessed informed consent.

Exclusion Criteria:

1. The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.

2. Other (non-diabetic) cause of vitreous haemorrhage

3. Other (non-diabetic) retinal vasculopathy in the study eye

4. Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage

5. Subjects whose planned vitrectomy was to have been combined with cataract surgery

6. Prior vitrectomy in the study eye

7. Visual acuity worse than 6/96 in the non study eye

8. Aphakia in the study eye

9. Pregnant (urine dipstick confirmed) or lactating women (women of childbearing potential should be advised to use appropriate contraception for three months following eye injection

10. Those with systemic or ocular contraindications to ranibizumab therapy

11. Sickle cell disease. Those with sickle trait may be included if there is no evidence of retinopathy in the non study eye.

12. Patients who have had an intravitreal injection of any therapeutic agent in the study eye

13. Subjects with active concomitant disease in the study eye, including uveitis and infection

14. Subjects with inadequate pupil dilation in the study eye, or other cause of significantly impaired fundus view

15. Subjects with potentially visually significant cataract in the study eye

16. Subjects who have undergone intraocular surgery in the study eye less than 6 months prior to screening with the exception of cataract surgery, which must have been at least 2 months prior to screening

17. Subjects who have commenced medications that target haemostasis within 3 months of screening, including antithrombotic, antiplatelet and anticoagulant therapy, or who are likely to commence or alter such medications during the course of the study. Subjects who have commenced treatment with these agents at least 3 months prior to screening, and who are stable on treatment, are eligible for inclusion.

18. Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year

19. Patients unable or unwilling to give informed consent

20. Patients unable or unwilling to return for follow up over 12 months

21. Any other condition or situation that, in the opinion of the investigator, may prevent the patient from complying with the study protocol