E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Geographic Atrophy secondary to age-related macular degeneration |
ATROFIA GEOGRAFICA SECONDARIA A DEGENERAZIONE MACULARE LEGATA ALL¿ET¿ |
|
E.1.1.1 | Medical condition in easily understood language |
Geographic Atrophy (GA) is an advanced form of age-related macular degeneration. It is a progressive, irreversible condition of the eye that causes severe loss of visual function. |
L'atrofia geografica ¿ una forma avanzata di degenerazione maculare legata all'et¿. E' una condizione progressiva e irreversibile dell'occhio che causa una severa perdita delle funzioni visive. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063947 |
E.1.2 | Term | Geographic atrophy |
E.1.2 | System Organ Class | 100000004853 |
|
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 |
To evaluate the long-term safety and tolerability of intravitreal (ITV) injections of 10 mg lampalizumab |
valutare la sicurezza e la tollerabilit¿ a lungo termine di iniezioni intravitreali (ITV) da 10 mg di lampalizumab |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of both treatment and the Week 96 visit - Agreement to remain abstinent or use a reliable form of contraception among all men and women of child-bearing potential
|
- Precedente arruolamento nello studio GX29176 (NCT02247479) o GX29185 (NCT02247531) , nonché il completamento del relativo trattamento e della visita della Settimana 96 - Consenso a praticare l'astinenza o ad adottare metodi contraccettivi affidabili per tutte le donne e gli uomini in età fertile |
|
E.4 | Principal exclusion criteria |
- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Predisposition to or history of increased risk of infection - Pregnancy or lactation |
- Concomitante condizione oculare che rappresenti una controindicazione all’uso di lampalizumab, o che possa interferire con l’interpretazione dei risultati dello studio o che esponga il paziente al rischio elevato di complicanze correlate al trattamento. - Qualsiasi altra patologia, disfunzione metabolica, obiettività o referto di laboratorio concomitante che rappresenti una controindicazione all’uso di lampalizumab, o che possa interferire con l’interpretazione dei risultati dello studio o che esponga il paziente al rischio elevato di complicanze correlate al trattamento. - Predisposizione a o anamnesi positiva per aumento del rischio di infezione - Gravidanza o allattamento, |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of participants with ocular adverse events (AEs) by Severity 2. Percentage of participants with systemic (non-ocular) AEs by Severity |
1. Percentuale di partecipanti con eventi avversi oculari per severità 2. Percentuale di partecipanti con eventi avversi sistemici (non oculari) per severità. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
For 1 and 2: Approximately 2 years |
Per 1 e 2: approssimativamente 2 anni |
|
E.5.2 | Secondary end point(s) |
Not applicable |
Non applicabile |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicabile |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
- Biomarker - Immunogenicity |
- Biomarker - Immunogenicit¿ |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 |
Australia |
Brazil |
Canada |
Mexico |
Peru |
Russian Federation |
Turkey |
United States |
Austria |
Belgium |
Denmark |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Portugal |
Slovakia |
Spain |
Sweden |
Switzerland |
United Kingdom |
Argentina |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |