E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular age-related macular degeneration (wet AMD) |
Degeneración macular relacionada con la edad (DMRE exudativa) |
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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 |
Enfermdad ocular crónica,provoca visión borrosa o1punto ciego campo visual dbido1serie d vasos sanguíneos anómalos q tienn pérdidas d fluid o sangr n la part d la retina responsabl d la visión cntral |
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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. |
Determinar la eficacia de 2,0 mg de OPT-302 intravítreo cuando se administra en combinación con 0,5 mg de ranibizumab intravítreo en participantes con DMRE neovascular |
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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. |
Los objetivos secundarios del estudio son determinar los efectos de 2,0 mg de OPT-302 intravítreo cuando se administra en combinación con 0,5 mg de ranibizumab intravítreo desde el inicio hasta (y en) la semana 52, según lo determine: La eficacia: • Cambios en la puntuación de las letras de AVMC en ETDRS • Cambios en los parámetros anatómicos (área NVC, CST, quistes SRF e IR) • Cambios en el cuestionario de función visual de 25 elementos del Instituto Oftalmológico Nacional (NEI-VFQ-25) de resultados comunicados por los participantes (RCP). La seguridad: • Incidencia de acontecimientos adversos (AA) • Deterioro en la puntuación de la AVMC en el ETDRS • Incidencia de formación de AAF La farmacocinética: • Parámetros farmacocinéticos de 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. |
• Hombres o mujeres participantes de al menos 50 años de edad. • Lesión de NVC subfoveal activa o lesión de NVC juxtafoveal con implicación foveal secundaria a la DMRE en el ojo evaluado. • Una puntuación de la AVMC en el ETDRS de entre 60 y 25 (incluidos) en el ojo evaluado |
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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. |
Ojo evaluado: • Cualquier tratamiento previo para la DMRE neovascular. • Trastornos oculares clínicamente significativos (distintos de la DMRE neovascular), que pueden, en opinión del investigador, interferir con la evaluación de la AVMC, la evaluación de la seguridad o la obtención de imágenes del fondo de ojo. • Cualquier afección en curso (o antecedente de) social, psicológica o médica que impida la inscripción en el estudio. Nota: también podrán aplicarse otros criterios de exclusión del protocolo |
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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 |
Cambio medio en las letras de agudeza visual con la mejor corrección (AVMC) en el estudio de tratamiento precoz de la retinopatía diabética (ETDRS) desde el inicio hasta la semana 52 |
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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. |
Eficacia: • Proporción de participantes que alcanzan 10 o más letras de la agudeza visual con la mejor corrección (AVMC) en el estudio de tratamiento precoz de la retinopatía diabética (ETDRS) desde el inicio hasta la semana 52 • Proporción de participantes que alcanzan 15 o más letras de la agudeza visual con la mejor corrección (AVMC) en el estudio de tratamiento precoz de la retinopatía diabética (ETDRS) desde el inicio hasta la semana 52 • Proporción de participantes con ausencia, tanto de quistes de líquido subretiniano (LSR) como intrarretinales (IR) mediante TCO-DE en la semana 52 • Cambio en la zona de la neovascularización coroidea (NVC) por angiografía con fluoresceína (AF) desde el inicio hasta la semana 52 • Cambio en el grosor del subcampo central (GSC), mediante tomografía de coherencia óptica de dominio espectral (TCO-DE) desde el inicio hasta la semana 52 • Cambio en la puntuación compuesta del cuestionario de función visual de 25 elementos del Instituto Oftalmológico Nacional (NEI VFQ-25) desde el inicio hasta la semana 52 • Cambios en la puntuación media compuesta de 25 preguntas. Un cambio medio mayor significa una mejora general en la función visual |
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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 |
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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 | 10 |
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 | 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 |
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 | |
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 |