E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pacientes con neovascularización coroidea (NVC) subfoveal secundaria a degeneración macular asociada a la edad (DMAE). |
|
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 |
En este estudio de ampliación se evaluarán la seguridad y la tolerabilidad a largo plazo de las inyecciones intravítreas múltiples de ranibizumab realizadas sin enmascaramiento en pacientes con neovascularización coroidea (NVC) subfoveal secundaria a degeneración macular asociada a la edad (DMAE), tras haber recibido tratamiento previo con ranibizumab en alguno de dos estudios aún en curso, CRFB002A2302 (EXCITE) o CRFB002A2303 (SUSTAIN). El objetivo primario del estudio será evaluar la seguridad ocular y extraocular de Lucentis® durante el período de estudio de 24 meses. |
|
E.2.2 | Secondary objectives of the trial |
El objetivo secundario principal será la modificación media de la agudeza visual desde la determinación inicial hasta las determinaciones realizadas en los Meses 6, 12, 18 y 24. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion: • Finalización por parte del paciente del período de tratamiento de 12 meses de los estudios CRFB002A2302 (EXCITE) o CRFB002A2303 (SUSTAIN) • Consentimiento informado del paciente para la participación en este estudio
|
|
E.4 | Principal exclusion criteria |
Exclusion: • Participación simultánea del paciente en otros ensayos clínicos |
|
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 |
|
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 | Information not present in EudraCT |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 |
|
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
| |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |