E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exudative senile macular degeneration of retina |
Degeneración macular exudativa de la retina asociada a la edad |
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E.1.1.1 | Medical condition in easily understood language |
Retina damage due to the growth of abnormal blood vessels |
Daño en la retina debido al crecimiento de vasos sanguíneos anormales |
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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 | 18.0 |
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in best-corrected visual acuity (BCVA) from Baseline to Week 48 |
Demostrar que RTH258 6 mg no es inferior a aflibercept 2 mg con respecto al cambio en la agudeza visual mejor corregida (BCVA) desde el inicio del estudio hasta la semana 48. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA from Baseline averaged over the period Week 36 to Week 48 To estimate the proportion of q12 subjects (1 injection every 12 weeks) and its predictive value up to Week 48 in the RTH258 6 mg treatment arm To evaluate the efficacy of RTH258 6 mg relative to aflibercept 2 mg over the time period up to Week 96 by assessing changes in: BCVA, anatomical parameters and the ?q8 treatment need? To assess visual function-related, subject reported outcomes. To assess safety and tolerability of RT258 relative to the comparator |
Demostrar que RTH258 6 mg no es inferior a aflibercept 2 mg con respecto al cambio en la BCVA desde el inicio del estudio y el promedio en el periodo de las semanas 36 y 48. Calcular la proporción de sujetos con tratamiento c12 (1 inyección cada 12 semanas) y el valor predictivo hasta la semana 48 en el grupo tratado con RHT258 6 mg. Evaluar la eficacia de RTH258 6 mg respecto a aflibercept 2 mg en el periodo hasta la semana 96 mediante la evaluación de los cambios en: BCVA, parámetros anatómicos y la "necesidad de tratamiento c8". Evaluar los resultados relacionados con la función visual y notificados por el sujeto. Evaluar la seguridad y la tolerabilidad de RTH258 6 mg con relación al comparador. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The objective of this pharmacogenetic assessment is to identify genetic factors which may be related to nAMD, predict response to anti-VEGF treatment, and predict genetic predisposition to side effects. |
El objetivo de este estudio farmacogenético es identificar factores genéticos que pueden estar relacionados con nAMD, predecir la respuesta a tratamiento anti-VEGF y predecir la predisposición genética a efectos adversos. |
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E.3 | Principal inclusion criteria |
- Subjects must give written informed consent - Subjects must be 50 years of age or older - Active CNV lesions secondary to AMD that affect the central subfield in the study eye - Total area of CNV must comprise as stated in the protocol Other protocol-defined inclusion criteria may apply. |
- Los sujetos deben dar su consentimiento informado por escrito. - Los sujetos deben tener 50 años de edad o más. - Lesiones activas de CNV secundaria a DMA que afecten al subcampo central en el ojo del estudio. - El área total de la CNV debe abarcar lo que marca el protocolo. Se pueden aplicar otros criterios de inclusión definidos en el protocolo. |
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E.4 | Principal exclusion criteria |
- Any active intraocular or periocular infection or active intraocular inflammation in either eye - Central subfield of the study eye affected by fibrosis or geographic atrophy - Subject has received any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time. - History or evidence of the following in the study eye: - Intraocular or refractive surgery - Uncontrolled glaucoma as defined in the protocol - Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib (MACUGEN®) within the 4 week period prior to Baseline, or with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior to Baseline - Stroke or myocardial infarction or uncontrolled blood pressure Other protocol-defined exclusion criteria may apply. |
- Cualquier infección intraocular o periocular activa o inflamación intraocular activa en uno de los ojos. - Subcampo central del ojo del estudio afectado por fibrosis o atrofia geográfica. - El sujeto ha recibido algún tratamiento aprobado o en investigación para la DMA neovascular (que no sean suplementos vitamínicos) en el ojo del estudio en cualquier momento. - Cualquier antecedente o evidencia siguiente en el ojo del estudio: - Cirugía refractiva o intraocular. - Glaucoma no controlado según definido en el protocolo. - Tratamiento con aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib (MACUGEN®) en las 4 semanas anteriores al inicio del estudio, o con ranibizumab, 0,5 mg (LUCENTIS®) en las 2 semanas anteriores al inicio del estudio. - Ictus o infarto de miocardio o presión arterial no controlada. Se pueden aplicar otros criterios de exclusión definidos en el protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in BCVA from baseline to week 48 |
Cambio en la BCVA desde el inicio del estudio hasta la semana 48. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, Week 48 |
Inicio del estudio, Semana 48. |
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E.5.2 | Secondary end point(s) |
- Average change in BCVA from Baseline over the period Week 36 through Week 48. For each subject, this endpoint is defined as the average of the changes from baseline to Weeks 36, 40, 44 and 48. - q12 treatment status at Week 48 for subjects randomized to RTH258 6 mg. - q12 treatment status at Week 48 within the subjects randomized to RTH258 6 mg, with no q8 need during the 1st q12 cycle (Week 16 and Week 20). |
- Promedio del cambio en la BCVA desde el inicio del estudio en el periodo entre las semanas 36 y 48. Para cada sujeto, este criterio de valoración se define como el promedio de los cambios desde el inicio del estudio hasta las semanas 36, 40, 44 y 48. - Estado del tratamiento c12 en la semana 48 (únicamente para los sujetos aleatorizados a RTH258 6 mg) - Estado del tratamiento c12 en la semana 48 sin necesidad de c8 durante el primer ciclo c12 (en la semana 16, semana 20) (únicamente para los sujetos aleatorizados a RTH258 6 mg) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, weeks 36, 40, 44 and 48 Week 48 Week 48 |
Inicio del estudio, Semanas 36, 40, 44 y 48. Semana 48 Semana 48 |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
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 | 2 |
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 | 177 |
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 |
Austria |
Belgium |
Croatia |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Netherlands |
Norway |
Poland |
Portugal |
Russian Federation |
Singapore |
Slovakia |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
United Kingdom |
Vietnam |
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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
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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 | 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 |