Subconjunctival bevacizumab on eyes with recent onset of cornea neovascularisatio
- Conditions
- Corneal neovascularisationEye Diseases
- Registration Number
- ISRCTN35052615
- 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. Male or female over 18 years of age
2. Presence of blood vessels extending 2 mm form the limbus onto the cornea
3. Co-existent corneal condition causing neovascularisation that is present for no more than 6 months
4. Ability to understand and provide consent to participate in the study and willingness to follow study instructions and likely to complete all required visits
1. Patients with corneal neovascularisation of greater than 6 months duration
2. Presence of corneal conditions that may be worsened with bevacizumab including active corneal melting, persistent epithelial defects, active infective keratitis
3. A history of cardiovascular or cerebro-vascular event in the previous 6 months
4. Uncontrolled hypertension defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90mmHg
5. Pregnancy or breastfeeding
6. Current or recent (less than 3 months) use of bevacizumab into the study eye
7. Patient with history of steroid responsiveness or uncontrolled intraocular pressure
8. Subject hypersensitive to bevacizumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in area of corneal neovascularisation at 3 months compared to baseline by image analysis of digital slit lamp photos
- Secondary Outcome Measures
Name Time Method Measured from baseline to 3 months:<br>1. Change in visual acuity<br>2. Change in corneal signs including:<br>2.1. Presence of and size of epithelial defects<br>2.2. Signs of corneal melting or thinning using pentacam<br>2.3. Lipid keratopathy<br>2.4. Central endothelial cell counts using specular microscopy<br>2.5. Changes in lumen diameter of main vessels<br>2.6. Indirect assessments of vessel permeability ? change in area of lipid keratopathy, corneal clarity by pentacam imaging<br>3. Change in normal conjuncitval blood vessels. Systematic digital photos of 4 quadrants of each patients conjunctiva will also be taken and compared after 3 months of treatment. The aim is to see whether bevacizumab may have an effect in reducing normal blood vessels during the treatment period compared to the control group. <br>4. The proportion of adverse events in each arm<br>5. Physician assessment of improvement compared with digital assessment