Randomised controlled trial of Intravitreal Bevacizumab vs. conventional treatment for proliferative diabetic retinopathy. - Randomised controlled trial of Intravitreal Bevacizumab vs. conventional treatment for proliferative
- Conditions
- Proliferative diabetic retinopathy
- Registration Number
- EUCTR2007-000658-30-IE
- Lead Sponsor
- Royal Victoria Eye and Ear hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
20 patients with new onset, bilateral, high risk proliferative diabetic retinopathy (DRS criteria) will be recruited.
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
Only eye
Women of childbearing potential
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effectiveness of intravitreal bevacizumab in treating proliferative diabetic retinopathy when compared with conventional treatment. <br><br>Primary outcomes: <br>1. Best corrected visual acuity at 6 months <br>2. Neovascularisation. <br>3. Need for panretinal photocoagulation. <br>4. Need for vitrectomy <br>5. Median deviation in visual fields at 6 months ;Secondary Objective: Secondary outcomes: Quality of life (VFQ 25 questionnaire). ;Primary end point(s): Primary outcomes: <br>1. Best corrected visual acuity at 6 months <br>2. Neovascularisation. <br>3. Need for panretinal photocoagulation. <br>4. Need for vitrectomy <br>5. Median deviation in visual fields at 6 months
- Secondary Outcome Measures
Name Time Method