Corneal neovascularisation MedDRA version: 9.1 Level: LLT Classification code 10055665 Term: Corneal neovascularisation
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 216974-75-3
Other descriptive name: BEVACIZUMABUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinical features of corneal neovascularization of recent onset. Both superficial and deep neovascularization will be recruited with no attempt to stratify these patients. The conditions that will be recruited for enrolment will include: 1. Infective corneal diseases a. Post bacterial/fungal/amoebic keratitis b. Herpetic keratitis 2. Corneal lnflammatory conditions a. Corneal graft rejection b. Corneal suture/ post surgical vascularisation c. Ocular rosacea d. Contact lens associated vascularisation e. Peripheral corneal ulceration and melting disorders f. Chemical injury 3. Systemic inflammatory conditions a. Stevens-Johnson syndrome b. Mucus membrane pemphigoid c. Atopic keratoconjunctivitis Inclusion criteria: Will include the following: • Male or female over 18 years of age • Presence of blood vessels extending 2 mm form the limbus onto the cornea • Co-existent condition from list above causing neovascularisation that is present for no more than 6 months • Ability to understand and provide consent to participate in the study and willingness to follow study instructions and likely to complete all required visits 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with corneal neovascularization of greater than 6 months duration • Presence of corneal conditions that may be worsened with bevacizumab including active corneal melting, persistent epithelial defects, active infective keratitis • a history of cardiovascular or cerebro-vascular event in the previous 6 months • Uncontrolled hypertension defined as systolic blood pressure >160 mmHg or diastolic blood pressure >90mmHg • Pregnancy or breastfeeding. • Current or recent (<3 months) use of bevacizumab into the study eye • Patient with history of steroid responsiveness or uncontrolled intraocular pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and efficacy of Avastin in corneal neovascularisation;Secondary Objective: 1. Change in visual acuity 2. Change in corneal signs 3. Change in normal conjunctival blood vessels 4. Adverse events 5. Accuracy of physician assessments 6. Patient evaluation of intervention;Primary end point(s): Change in area of corneal neovascularisation, on digital photography, from baseline to 3 months | — |
Countries
United Kingdom
Outcome results
None listed