Preoperative intravitreal ranibizumab for persistent diabetic vitreous haemorrhage: A randomized, double-masked, controlled study - Vitreous Haemorrhage Study

Phase 1

• Conditions: Retinopathy is a well recognised complication of diabetes and is a leading cause of vision loss in this patient group. The severity of diabetic retinopathy varies, but in its most severe form (proliferative diabetic retinopathy or PDR), ocular ischaemia causes abnormal new blood vessels to grow in the retina. These fragile new vessels may bleed into the vitreous cavity. The resulting vitreous haemorrhage impairs vision and prevents further therapy.; MedDRA version: 12. Level: LLT Classification code 10047655 Term: Vitreous Haemorrhage

• Registration Number: EUCTR2009-015559-25-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-29
• Study Completion: 2015-10-20
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 at least 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified