Proliferative diabetic retinopathy MedDRA version: 13 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ranibizumab
CAS Number: SO1LA04
Other descriptive name: n/a
Concentration unit: mg/ml milli
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion 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: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does injection into the eye of ranibizumab prior to undergoing vitrectomy surgery improve vision in patients with proliferative diabetic retinopathy?;Secondary Objective: Does injecting ranibizumab into the eye before undergoing vitrectomy surgery for proliferative diabetic retionopathy: Make the surgery easier? Reduce the incidence of bleeding after the operation? Change the growth of new blood vessels in the retina? Alter the amount of retinal detachment present? Alter the blood flow to the macula? Additionally, the study seeks to establish the levels of the drug in the eye at an interval after injection and compare this with levels detectable in the blood.;Primary end point(s): Absolute visual acuity at 12 weeks following surgery. | — |
Countries
United Kingdom
Outcome results
None listed