E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
neovascularización coroidea subfoveolar asociada a degeneración macular de tipo húmedo asociada a la edad |
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MedDRA Classification |
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 |
El criterio primario de valoración de la eficacia es la no inferioridad del sistema oftálmico Epi-Rad90™ frente a un control activo (Lucentis™) en lo que respecta al porcentaje de sujetos que pierden menos de 15 optotipos en la puntuación de agudeza visual con corrección a los 12 meses frente al valor basal, con un margen de no inferioridad del 20% |
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E.2.2 | Secondary objectives of the trial |
1. Porcentaje de sujetos que recuperan ≥ 15 optotipos ETDRS 2. Porcentaje de sujetos que recuperan ≥ 0 optotipos ETDRS 3. Variación media de la agudeza visual según ETDRS 4. Variación en el tamaño total de la lesión mediante angiografía fluoresceínica 5. Variación en el tamaño total de la NVC mediante angiografía fluoresceínica 6. Número de inyecciones de rescate de Lucentis™ |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must be age 50 or older; Best Corrected VA 20/40 to 20/320 Snellen All Lesion Subtypes: Predominantly Classic, Minimally Classic, or Occult Lesions MUST be Active. Subretinal Hemorrhage less than 50% of total lesion size & not in subfoveal space; Minimally Classic and Occult Lesions must have evidence of recent disease progression defined as: Presence of Subretinal Hemorrhage and/or Fluid and/or Lipid OR Loss of 1 or more lines of Vision / past 6 months OR FA documented lesion growth by ≥ 10% / past 6 months; Women Post-Menopausal ≥1 year or Surgically Sterilized |
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E.4 | Principal exclusion criteria |
Subjects with prior AMD Treatment Subjects with Concomitant Disease in the Study Eye (Uveitis, DR, ocular infections, etc.) Subjects with Glaucoma (IOP ≥ 30 mmHg) Subjects with Retinal Vasculopathies – RVO, Diabetic Retinopathy Subjects with any subfoveal scarring, atrophy, or hemorrhage CNV lesion has significant scarring and/or atrophy; Diagnosed Diabetes Mellitus; Previous Intra-ocular surgery, excluding cataract surgery |
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E.5 End points |
E.5.1 | Primary end point(s) |
El criterio primario de valoración de la eficacia es la no inferioridad del sistema oftálmico Epi-Rad90™ frente a un control activo (Lucentis™) en lo que respecta al porcentaje de sujetos que pierden menos de 15 optotipos en la puntuación de agudeza visual con corrección a los 12 meses frente al valor basal, con un margen de no inferioridad del 20% |
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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 | Information not present in EudraCT |
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
NeoVista device + Lucentis is compared to Lucentis |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
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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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Last visit of last subject enrolled in 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 | |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 36 |