E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The main secondary objective will be mean change from baseline in BCVA at 6, 12, 18 and 24 months |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion: • Completion of 12 month treatment period of studies CRFB002A2302 (EXCITE) or -CRFB002A2303 (SUSTAIN) • Patient consent will be required to be enrolled
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E.4 | Principal exclusion criteria |
Exclusion: • Concurrent participation in another clinical trial
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |