Secondary to Age-related Macular Degeneration (AMD) Clinical Trial
Official title:
A Phase IV, Long-term, Open-label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
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
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigational Site | Melbourne | |
| Belgium | Novartis Investigative Site | Laeken | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liege | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bonn | |
| Germany | Novartis Investigative Site | Bremen | |
| Germany | Novartis Investigative Site | Chemnitz | |
| Germany | Novartis Investigative Site | Duesseldorf | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Koeln | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Siegburg | |
| Germany | Novartis Investigative Site | Tubingen | |
| Germany | Novartis Investigative Site | Wuerzburg | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Debrecen | |
| Israel | Novartis Investigative Site | Petach-Tikva | |
| Israel | Novartis Investigative Site | Tel - Hashomer | |
| Israel | Novartis Investigative Site | Tel-Aviv | |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Nijmegen | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Porto | |
| Spain | Novartis Investigative Site | Alicante | |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Santiago de Compostela | |
| Spain | Novartis Investigative Site | Valencia | |
| Turkey | Novartis Investigative SIte | Ankara | |
| United Kingdom | Novartis Investigative Site | Bristol | |
| United Kingdom | Novartis Investigative Site | Southampton | |
| United Kingdom | Novartis Investigative Site | West Midlands | |
| United Kingdom | Novartis Investigative Site | Wolverhampton |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Australia, Belgium, Germany, Hungary, Israel, Netherlands, Portugal, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | ||
| Secondary | 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. | No |