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 geográfica secundaria a degeneración macular relacionada con la edad |
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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. |
Atrofia Geográfica (AG) es una forma avanzada de la degeneración macular relacionada con la edad. Es una enfermedad progresiva e irreversible del ojo que causa la pérdida severa de la función visual. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063947 |
E.1.2 | Term | Geographic atrophy |
E.1.2 | System Organ Class | 100000004853 |
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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 |
Evaluar la seguridad y la tolerabilidad a largo plazo de la inyección intravítrea (ITV) de lampalizumab en dosis de 10 mg |
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E.2.2 | Secondary objectives of the trial |
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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 |
- Participación previa en el estudio GX29176 (NCT02247479) o GX29185 (NCT02247531) y finalización del tratamiento del estudio en la visita de la semana 96.
- Compromiso de practicar la abstinencia o usar métodos anticonceptivos tanto para varones como para mujeres en edad fértil. |
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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 |
- Trastornos oculares concurrentes que que contraindique el uso de lampalizumab, que pueda afectar a la interpretación de los resultados del estudio o que suponga un alto riesgo de complicaciones del tratamiento.
- Enfermedad concurrente, disfunción metabólica o hallazgo en la exploración física o resultado en los análisis clínicos haga sospechar de forma razonable una enfermedad o proceso que contraindique el uso de lampalizumab, que pueda afectar a la interpretación de los resultados del estudio o que suponga un alto riesgo de complicaciones del tratamiento.
- Predisposición o antecedentes de un riesgo elevado de infección.
- Embarazo o lactancia. |
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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. Porcentaje de participantes con acontecimientos oculares adversos (AA) por Severidad 1. Porcentaje de participantes con acontecimientos adversos (AA) sistémicos (no oculares) por Severidad |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
For 1 and 2: Approximately 2 years |
Para 1 y 2: Aproximadamente 2 años |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 |
- Biomarcadores - Inmunogenecidad |
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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.8.3 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 171 |
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 | No |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Denmark |
France |
Germany |
Hungary |
Italy |
Mexico |
Netherlands |
Peru |
Poland |
Portugal |
Russian Federation |
Slovakia |
Spain |
Sweden |
Switzerland |
Turkey |
United Kingdom |
United States |
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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
|
The end of the study is defined as the date when the last patient, last visit (LPLV) occurs |
El estudio se considera finalizado en la fecha de la última visita del último paciente (UVUP). |
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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 | 10 |
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 |