A randomised, single-masked, Phase IV pilot study of the efficacy and safety of adjunctive intravitreal Avastin® (bevacizumab) in the prevention of early postoperative vitreous haemorrhage following diabetic vitrectomy - Intravitreal Avastin® in diabetic vitrectomy
- Conditions
- Vitreous haemorrhage secondary to proliferative diabetic retinopathy
- Registration Number
- EUCTR2007-000780-21-GB
- Lead Sponsor
- Moorfields Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Non-clearing or recurrent vitreous haemorrhage due to proliferative diabetic retinopathy – indicated for PPV.
Visual acuity better than perception of light.
Patient fit for and agreed to have pars plana vitrectomy
Age > 20 years old
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
Previous vitrectomy
Ocular and systemic contra-indication for vitrectomy
Unfit for local or general anaesthesia
Inability to obtain visual acuity, fundus imaging or fluorescein angiogram.
Reduced potential visual acuity due to corneal or optic nerve disease, or amblyopia
Previous intravitreal Avastin® injection in either eye
Inability to give informed consent
Inability to comply with follow-up visit and investigation
Women of child-bearing age or currently breast feeding
Recent (< 1 month) acute myocardial infarct, transient ischaemic attack or stroke.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method