Corneal neovascularization MedDRA version: 9.1 Level: LLT Classification code 10055665 Term: Corneal neovascularisation
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1250-
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Recent thrombo-embolic or ischemic occurrences (last 6 months). 2. Systemic hypertension not treated or not adequately controlled by therapy. 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed