Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

• Status: Completed
• Trial end date: 2013-03-12
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy.

Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome.

In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Patients of either sex aged 18 years or over

2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:

• Current regular use of insulin for the treatment of diabetes

• Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes

• Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)

3. Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes

4. Ability to return for study visits

5. Ability to give informed consent throughout the duration of the study

Exclusion Criteria:

1. Hypersensitivity to the active substance or to any of the excipients.

2. Active or suspected ocular or periocular infections.

3. Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment

4. Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery

5. Active severe intraocular inflammation

6. Previous vitrectomy surgery on study eye

7. Vision in fellow eye 3/60 or worse

8. Uncontrolled glaucoma

9. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation

10. Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation

11. Pregnancy or lactation

12. Male or female unwilling to use contraception