Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
- Sponsor
- Novartis
- Study ID
- NCT00504959
- Phase
- PHASE4
- Status
- Completed
Conditions
- Secondary to Age-related Macular Degeneration (AMD)
- Subfoveal Choroidal Neovascularization (CNV)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ranibizumab — DRUG
Study Details
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
Key Dates
- First listed
- Jul 20, 2007
- Start date
- Jul 31, 2007
- Status verified
- Mar 2016
- Primary completion
- Jan 31, 2010
- Completion
- Jan 31, 2010
Study Design
- Enrollment
- 234 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1ranibizumab
Primary Outcome Measure
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)