se of subconjunctival Bevacizumab (Avastin) in treatment of corneal neovascularization non curable with standard protocols (topical and sistemic steroids). - ND
- Conditions
- Corneal neovascularizationMedDRA version: 9.1Level: LLTClassification code 10055665Term: Corneal neovascularisation
- Registration Number
- EUCTR2007-007787-25-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Patients of either sex.
2.Majors
3.Afflicted with corneal neovascularization resulting from corneal pathology (trauma, burn, caustication, keratitis e.g. Herpetic, pemphigus or ocular pemphigoid, neovascularization of corneal transplantation), non responding to topical treatment and such that to reduce significantly visual function and/or jeopardize new corneal transplantation.
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
1.Recent thrombo-embolic or ischemic occurrences (last 6 months).
2.Systemic hypertension not treated or not adequately controlled by therapy.
3.Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To prove the effectiveness of this treatment;Secondary Objective: To prove the persistance of results obtained in time (at least in 9 months of therapy or until new corneal transplantation);Primary end point(s): At least 15% reduction of areas of corneal neovascularization and/or 20% reduction of areas of corneal deterioration within the first three Avastin administerings
- Secondary Outcome Measures
Name Time Method