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.
Conditions
Interventions
Trade Name: Lucentis
10 mg/ml solution for injection
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: • 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
Exclusion criteria: Exclusion: • Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Germany, Hungary, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed