A phase IV, long-term, open-label, multicenter extension study to evaluate the safety and tolerability of ranibizumab in subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Phase 4
- Conditions
- macular degenerationsubfoveal choroidal neovascularization secondary to age-related macular degeneration10047060
- Registration Number
- NL-OMON31158
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Signed informed consent
Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN) study.
Exclusion Criteria
Concurrent participation in another clinical trial, i.e. use of other investigational drugs at the time of enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Incidence and severity of oculair and non-oculair (Serious) Adverse<br /><br>Events</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy: Best corrected visual acuity<br /><br>Tolerability: number and percentage of patients that have to stop study<br /><br>medication due to an adverse event related to study medication.<br /><br>Safety: vital signs and results ophthalmic examination</p><br>