E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular age-related macular degeneration (wet AMD) |
Degenerazione maculare neovascolare legata all’età (DMLE) |
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E.1.1.1 | Medical condition in easily understood language |
Chronic eye disease that causes blurred vision or a blind spot in one´s visual field caused by abnormal blood vessels leaking fluid or blood into the part of the retina responsible for central vision |
Malattia cronica occhi causa visione offuscata o punto cieco in un campo visivo causato da vasi sang normali che fuoriescono fluido o sangue nella parte della retina responsabile della vis centrale |
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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 | SOC |
E.1.2 | Classification code | 10015919 |
E.1.2 | Term | Eye disorders |
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 | 20.0 |
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 determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD.
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Determinare l’efficacia di 2,0 mg di OPT-302 intravitreale somministrato in combinazione con 0,5 mg di ranibizumab intravitreale, in partecipanti con AMD neovascolare. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab from Baseline to (and at) Week 52 as determined by: Efficacy: • Changes in ETDRS BCVA letter score • Changes in anatomical parameters (CNV area, CST, SRF and IR cysts) • Changes in National Eye Institute 25-item Vision Function Questionnaire (NEI-VFQ-25) Participant Reported Outcomes (PROs). Safety: • Incidence of adverse events (AEs) • Deterioration in ETDRS BCVA letter score • Incidence of ADA formation Pharmacokinetic: • Pharmacokinetic parameters of OPT-302. |
Determinare gli effetti dell’aggiunta di 2,0 mg di OPT-302 intravitreale a 0,5 mg di ranibizumab intravitreale dal Basale fino alla (e alla) Settimana 52 in termini di: Efficacia: • Variazioni nel punteggio della massima acuità visiva corretta (BCVA) misurata con la scala ETDRS (Early Treatment Diabetic Retinopathy Study) per le lettere • Cambiamenti nei parametri anatomici (area di neovascolarizzazione coroideale [CNV], spessore del sottocampo centrale [CST], fluido sottoretinico [SRF] e cisti intraretiniche [IR]) • Cambiamenti negli esiti riferiti dal paziente (PRO) nel questionario sulla funzione visiva a 25 domande del National Eye Institute (NEI-VFQ-25) Sicurezza: • Incidenza di eventi avversi (EA) • Peggioramento del punteggio della BCVA misurata con la scala ETDRS per le lettere • Incidenza della formazione di anticorpi anti-OPT-302 (ADA) Farmacocinetica: • Farmacocinetica di OPT-302. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female participants at least 50 years of age. • Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. • An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. |
• Partecipanti maschi o femmine di almeno 50 anni di età. • Lesione CNV subfoveale attiva o lesione CNV iuxtafoveale con coinvolgimento foveale secondario all’AMD nell’occhio in studio. • Un punteggio di BCVA all’ETDRS compreso tra 60 e 25 lettere (incluse) per l’occhio in studio. |
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E.4 | Principal exclusion criteria |
Study Eye: • Any previous treatment for neovascular AMD. • Clinically significant ocular disorders (other than neovascular AMD), which may, in the investigator’s opinion, interfere with assessment of BCVA, assessment of safety, or fundus imaging. • Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
Note: other protocol exclusion criteria may also apply. |
Occhio in studio: • Qualsiasi trattamento precedente per AMD neovascolare • Disturbi oculari clinicamente significativi (diversi dall’AMD neovascolare) che, a giudizio dello sperimentatore, possono interferire con la valutazione della BCVA, la valutazione della sicurezza o le immagini del fondo oculare. • Qualsiasi infezione oculare o perioculare in corso
NOTE: possono applicarsi anche altri criteri di esclusione del protocollo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52 |
Variazione media dal basale alla settimana 52 della BCVA, misurata con la scala ETDRS per le lettere |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy: • Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52 • Proportion of participants gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters from Baseline to Week 52 • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by SD-OCT at Week 52 • Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) from Baseline to Week 52 • Change in central sub-field thickness (CST) by spectral domain optical coherence tomography (SD-OCT) from Baseline to Week 52 • Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score from Baseline to Week 52 • Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function. |
Efficacia • Percentuale di partecipanti che ottengono un punteggio di 10 o più di BCVA all’ETDRS sulle lettere dal basale alla settimana 52 • Percentuale di partecipanti che ottengono un punteggio di 15 o più della BCVA all’ETDRS sulle lettere dal basale alla settimana 52 • Percentuale di partecipanti con assenza di cisti sia SRF sia IR mediante tomografia a coerenza ottica nel dominio spettrale (SD-OCT) alla settimana 52 • Variazione dell’area CNV misurata mediante angiografia con fluoresceina (FA) dal basale alla settimana 52 • Variazione del CST rilevata da SD-OCT dal basale alla settimana 52 • Variazione del punteggio composito al questionario NEI VFQ-25 dal basale alla settimana 52 |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Iniezione sham |
Sham Injection |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 |
India |
Israel |
Korea, Republic of |
Malaysia |
Russian Federation |
Thailand |
Ukraine |
United States |
Bulgaria |
Denmark |
France |
Germany |
Hungary |
Italy |
Latvia |
Poland |
Spain |
United Kingdom |
Czechia |
Argentina |
Greece |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |