E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subfoveal choroidal neovascularization secondary to Age-Related Macular Degeneration (AMD) |
Degenerazione maculare senile con neovascolarizzazione coroideale in sede subfoveale |
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E.1.1.1 | Medical condition in easily understood language |
Age-Related Macular Degeneration caused by abnormal growth of vessels within the eye |
Degenerazione maculare senile causata dalla crescita anomala di capillari all¿interno dell¿occhio |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071129 |
E.1.2 | Term | Neovascular age-related macular degeneration |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 | 10067791 |
E.1.2 | Term | Wet macular degeneration |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 assess the safety and biomarker responses of various regimens of Fovista¿ when administered in combination with anti-VEGF agents, in treatment na¿ve and treatment experienced neovascular AMD subjects. |
Valutare la risposta in termini di sicurezza e biomarcatori ai diversi regimi di Fovista¿ somministrato in associazione ad agenti anti-VEGF in soggetti affetti da degenerazione maculare senile (AMD, age-related macular degeneration) sia na¿ve che gi¿ sottoposti a trattamento. |
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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 |
OPHTHALMIC INCLUSION CRITERIA: The following inclusion criteria apply to the study eye:
- Best corrected visual acuity in the study eye between 20/40 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization. Presence of Subfoveal CNV by FA or OCTA, or ICG or OCT (presence of fluid and hypereflective consistent with CNV).
GENERAL INCLUSION CRITERIA:
- Subjects of either gender aged =50 years. - Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication. - Provide written informed consent. - Ability to comply with study and follow-up procedures and return for all trial visits. |
CRITERI DI INCLUSIONE OFTALMINICI: I seguenti criteri di inclusione si applicano per l'occhio in studio:
- Migliore acuità visiva corretta nell'occhio in studio tra 20/40 e 20/200, inclusi. L’Acuità Visiva deve essere riconfermata al giorno 1 prima della randomizzazione - Presenza di “CNV attiva" subfoveale DA FA o OCTA, o ICG o OCT (presenza di fluido e iperreflessività consistente con CNV).
CRITERI DI INCLUSIONE GENERALI:
- Soggetti di entrambi i sessi di età = 50 anni. - Le donne devono acconsentire all’utilizzo di due metodi di contraccezione efficaci, essere in post-menopausa da almeno 12 mesi prima dell'entrata in studio, o chirurgicamente sterili; se di età fertile, un test di gravidanza sul siero deve essere effettuato entro 14 giorni prima della prima iniezione; il test deve risultare negativo. I due metodi di contraccezione efficaci devono essere in uso durante lo studio e per almeno 60 giorni dopo l'ultima dose di farmaco di studio assunta. - Fornire il Consenso Informato scritto. - Capacità di rispettare le procedure dallo studio e di follow-up e ritornare per tutte le visite previste.
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E.4 | Principal exclusion criteria |
OPHTHALMIC EXCLUSION CRITERIA:
- Subjects with atrophy or scar within 1 disc area (DA) of the center of the fovea are excluded. - Prior thermal laser in the macular region, regardless of indication. - Ocular or periocular infection in the past twelve (12) weeks. - History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant. - Previous therapeutic radiation in the region of the study eye.
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CRITERI DI ESCLUSIONE OFTALMICI:
- Sono esclusi soggetti con atrofia o cicatrice entro 1 disco ottico (DA) del centro della fovea - Qualsiasi precedente laser-termia nella regione maculare, indipendentemente dall’indicazione. - Qualsiasi infezione oculare o perioculare nelle ultimi dodici (12) settimane. - Storia di una delle seguenti condizioni o procedure nell'occhio in studio: distacco di retina regmatogeno, vitrectomia via pars plana, chirurgia di filtraggio (ad es trabeculectomia), dispositivo per il drenaggio del glaucoma, trapianto di cornea. - Precedente radiazioni terapeutiche nella regione dell'occhio in studio.
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E.5 End points |
E.5.1 | Primary end point(s) |
Biomarker Imaging Endpoints: Modalities: (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA) - CNV and/or CNV complex analysis with respect to area and/or volume and/or flow.
Safety Endpoints: - Severe Visual Acuity Loss (Proportion of subjects with >15 letter loss at Months 12 and 18) - Ophthalmic Adverse Events (AEs) - Systemic Adverse Events (AEs) - Laboratory data (blood: hematology, renal function, hepatic function and electrolytes).
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Endpoint di imaging dei biomarcatori: Modalità: angiografia con fluoresceina (Fluorescein Angiography, FA), angiografia al verde di indocianina (Indocyanine Green Angiography, ICGA), tomografia a coerenza ottica (Optical Coherence Tomography, OCT) e tomografia a coerenza ottica con angiografia (Optical Coherence Tomography Angiography, OCTA). Variazione del numero di copie (CNV) e/o analisi complessa della CNV rispetto all'area e/o al volume e/o al flusso.
Endpoint di sicurezza: Grave perdita di acuità visiva (percentuale di soggetti con perdita >15 lettere ai Mesi 12 e 18); Eventi avversi oftalmici (AE); Eventi avversi sistemici (AE). Dati di laboratorio (sangue: ematologici, funzione renale, funzione epatica ed elettrolidi)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Following Month 0-8, 10-14 and 16-18 visits. |
Mesi seguenti 0-8, 10-14 e 16-18 visite |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 8 |
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 | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |