Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Phase 4
Completed
- Conditions
- Secondary to Age-related Macular Degeneration (AMD)Subfoveal Choroidal Neovascularization (CNV)
- Interventions
- Registration Number
- NCT00504959
- Lead Sponsor
- Novartis
- Brief Summary
This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
- Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303
Exclusion Criteria
- Concurrent participation in another clinical trial, i.e. use of other investigational drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ranibizumab ranibizumab
- Primary Outcome Measures
Name Time Method Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml)
- Secondary Outcome Measures
Name Time Method Efficacy assessed by mean change in BCVA from Baseline at M 6, 12, 18, and 24. Number of injections with ranibizumab. Safety assessed by AEs and SAEs leading to premature discont. of study drug, vital signs, and ophthalmic exams.
Trial Locations
- Locations (3)
Novartis Investigative SIte
🇹🇷Ankara, Turkey
Novartis Investigational Site
🇦🇺Melbourne, Australia
Novartis Investigative Site
🇬🇧Wolverhampton, United Kingdom