Corneal neovascularisation Eye Diseases Corneal neovascularisation
Conditions
Interventions
The intervention is subconjunctival bevacizumab or placebo by subconjunctival injection. The treatment protocol for each intervention will be:
1. Subconjunctival bevacizumab (active arm): a volume of
Sponsors
Moorfields Eye Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in area of corneal neovascularisation at 3 months compared to baseline by image analysis of digital slit lamp photos | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured from baseline to 3 months: 1. Change in visual acuity 2. Change in corneal signs including: 2.1. Presence of and size of epithelial defects 2.2. Signs of corneal melting or thinning using pentacam 2.3. Lipid keratopathy 2.4. Central endothelial cell counts using specular microscopy 2.5. Changes in lumen diameter of main vessels 2.6. Indirect assessments of vessel permeability ? change in area of lipid keratopathy, corneal clarity by pentacam imaging 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. 4. The proportion of adverse events in each arm 5. Physician assessment of improvement compared with digital assessment | — |
Countries
United Kingdom
Outcome results
None listed