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
- Conditions
- Proliferative diabetic retinopathyEye DiseasesDiabetic retinopathy
- Registration Number
- ISRCTN79120387
- Lead Sponsor
- Moorfields Eye Hospital NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. A diagnosis of non-clearing or recurrent vitreous haemorrhage due to proliferative diabetic retinopathy - indicated for Pars Plana Vitrectomy (PPV)
2. Visual acuity better than perception of light
3. Patient fit for and agreed to have PPV
4. >20 years old
1. Previous vitrectomy
2. Ocular and systemic contra-indication for vitrectomy
3. Unfit for local or general anaesthesia
4. Inability to obtain visual acuity, fundus imaging or fluorescein angiogram
5. Reduced potential visual acuity due to corneal or optic nerve disease, or amblyopia
6. Previous intravitreal Avastin® injection in either eye
7. Inability to give informed consent
8. Inability to comply with follow-up visit and investigation
9. Women of childbearing age
10. Recent (<1 month) acute myocardial infarct, Transient Ischaemic Attack (TIA) or stroke
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method