A prospective, randomised controlled trial of Ranibizumab pre-treatment in Diabetic Vitrectomy – a pilot study. - A pilot RCT of ranibizumab in diabetic vitrectomy - The RaDiVit Study

Phase 1

Conditions: Proliferative diabetic retinopathy
MedDRA version: 13Level: LLTClassification code 10036857Term: Proliferative diabetic retinopathy

Registration Number: EUCTR2010-024062-22-GB

Lead Sponsor: Moorfields Eye Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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:
a)Current regular use of insulin for the treatment of diabetes
b)Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
c)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

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

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 cerebrovascular accident, 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. Unwillingness to use contraception for the duration of the study