A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab 0.3 mg in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - ND
- Conditions
- wet age-related macular degeneration of retinaMedDRA version: 6.1Level: PTClassification code 10025409
- Registration Number
- EUCTR2005-005921-73-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Male or female patients 50 years of age or greater. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. The total area of CNV encompassed within the lesion must be 50 of hte total lesion area
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Previous treatment with intravitreally or intravenously administered Avasatin. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photodynamic therapy or pegaptanib sodium in the study eye within 30 days preceding day 1. Prior treatment in the study eye whit external-beam radiation terapy, vitreoctomy, or transpupillary thermotherapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method