E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Macular Edema (DME) |
Edema maculare diabetico |
|
E.1.1.1 | Medical condition in easily understood language |
DME is an accumulation of fluid in the macular region, the part of the retina that is responsible for fine detailed vision tasks. |
L'edema maculare diabetico è l'accumulo di fluido nella regione maculare, la regione della retina responsabile della visione dettagliata. |
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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 | 10057934 |
E.1.2 | Term | Diabetic macular edema |
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 ocular and systemic safety and tolerability of faricimab administered intravitreally in patients with DME |
• valutare la sicurezza e la tollerabilità oculari e sistemiche a lungo termine di faricimab per via intravitreale in pazienti con edema maculare diabetico |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Previous enrollment in and completion of Study GR40349 (YOSEMITE) or GR40398 (RHINE), without study or study drug discontinuation - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the final dose of study treatment |
- Precedente arruolamento e completamento dello studio GR40349 (YOSEMITE) o GR40398 (RHINE), senza interruzione dello studio o del trattamento con il farmaco in studio - Nelle donne in età fertile: consenso a praticare l’astinenza dai rapporti eterosessuali o a fare uso di metodi contraccettivi accettabili che garantiscano un tasso di insuccesso < 1% all’anno durante il periodo di trattamento e per almeno 3 mesi dopo l’ultima dose del trattamento in studio |
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E.4 | Principal exclusion criteria |
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final Intravitreal injection of faricimab - Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications - Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications - Requirement for continuous use of any medications or treatments indicated as prohibited therapy |
- Gravidanza o allattamento o intenzione di iniziare una gravidanza durante lo studio o nei 28 giorni successivi l’ultima iniezione IVT di faricimab - Presenza di altre patologie dell’occhio che suscitino il ragionevole sospetto di una malattia o condizione che rappresenti una controindicazione all’uso di faricimab, che potrebbe interferire con l’interpretazione dei risultati dello studio o che esponga il paziente ad alto rischio di complicanze correlate al trattamento - Presenza di altra patologia, disfunzione metabolica o referto di laboratorio che susciti il ragionevole sospetto di una malattia o condizione che rappresenti una controindicazione all’uso di faricimab, che potrebbe interferire con l’interpretazione dei risultati dello studio o che esponga il paziente ad alto rischio di complicanze correlate al trattamento - Necessità di uso continuo di medicinali o trattamenti indicati come terapie non ammesse |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence and severity of ocular adverse events
2. Incidence and severity of systemic (non-ocular) adverse events
|
1. Incidenza e severità degli eventi avversi oculari 2. Incidenza e severità degli eventi avversi sistemici (non oculari) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 and 2. Approximately 2 years |
1. e 2. approssimativamente 2 anni |
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E.5.2 | Secondary end point(s) |
|
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 | Yes |
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 |
Immunogenicity
|
Immunogenicità |
|
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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
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 |
China |
Hong Kong |
Israel |
Japan |
Korea, Republic of |
Mexico |
Peru |
Russian Federation |
Singapore |
Taiwan |
Thailand |
Turkey |
United States |
Austria |
Bulgaria |
Denmark |
France |
Germany |
Hungary |
Italy |
Poland |
Portugal |
Slovakia |
Spain |
Switzerland |
United Kingdom |
Czechia |
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
|
LVLS |
Ultima visita dell'ultimo paziente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |