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) - SECURE
Phase 1
- Conditions
- Study population will consist of patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) who received treatment in either of the two ongoing ranibizumab studies RFB002A2302 (EXCITE) or RFB002A2303 (SUSTAIN). It is estimated that approximately 200 patients will be screened and assigned to treatment from approximately 40 centers in Europe.
- Registration Number
- EUCTR2007-000743-95-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• Completion of 12 month treatment period of studies CRFB002A2302 (EXCITE) or -CRFB002A2303 (SUSTAIN) • Patient consent will be required to be enrolled
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
• Concurrent participation in another clinical trial, i.e. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of open-label ranibizumab administered to subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) who have been previously treated in either of the two ongoing ranibizumab studies RFB002A2302 (EXCITE) or RFB002A2303 (SUSTAIN). The primary objective of the study will be to assess the incidence and severity of ocular and non ocular adverse events during the 24 month study period.?;Secondary Objective: The main secondary objective will be mean change from baseline in BCVA at 6, 12, 18 and 24 months;Primary end point(s): The primary objective of this study (ocular and non-ocular safety) will be assessed based on the incidence and severity of treatment emergent ocular and non-ocular adverse events during the 24-month study period: The primary analysis will be the estimation of incidences of adverse events
- Secondary Outcome Measures
Name Time Method