E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Corneal neovascularisation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055665 |
E.1.2 | Term | Corneal neovascularisation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety and efficacy of Avastin in corneal neovascularisation |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in area of corneal neovascularisation, on digital photography, from baseline to 3 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |