E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreomacular Traction/ Symptomatic Vitreomacular Adhesion |
Tracción vitreomacular/adhesión vitreomacular sintomática |
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E.1.1.1 | Medical condition in easily understood language |
Vitreomacular Traction/ Symptomatic Vitreomacular Adhesion |
Tracción vitreomacular/adhesión vitreomacular sintomática |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070236 |
E.1.2 | Term | Vitreomacular adhesion |
E.1.2 | System Organ Class | 100000004853 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051065 |
E.1.2 | Term | Vitreomacular traction syndrome |
E.1.2 | System Organ Class | 100000004853 |
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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 observe the anatomical and functional outcomes of ocriplasmin over a 6-month follow-up period |
El objetivo de este estudio es observar los resultados anatómicos y funcionales de la ocriplasmina durante un período de seguimiento de 6 meses. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
No procede. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Ages Eligible for Study: 18 Years and older. - Genders Eligible for Study: Both. - Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT visible on Spectral Domain Optical Coherence Tomography (SD-OCT). - Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form. - Other protocol-defined inclusion criteria may apply. |
- Tener al menos 18 años de edad en el momento del consentimiento informado. - Criterio de inclusión: ambos sexos. - Haber sido diagnosticado de tracción vitreomacular/adhesión vitreomacular sintomática (TVM/AVMs), con pruebas de TVM focal visible en la tomografía de coherencia óptica de dominio espectral (TCO-DE). - El paciente participante debe haber leído, firmado y fechado un formulario de consentimiento informado aprobado por el Comité de Revisión Institucional/Comité Ético de Investigación Clínica - Pueden aplicarse otros criterios de inclusión definidios en el protocolo. |
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E.4 | Principal exclusion criteria |
- Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. - Hypersensitivity to ocriplasmin or any of the Jetrea excipients. - Active or suspected intraocular or periocular infection. - Presence of Epiretinal Membrane (ERM) over the macula at baseline. - Broad VMT/VMA >1500 microns at Baseline. - History of vitrectomy in the study eye. - History of laser photocoagulation to the macula in the study eye - Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period - Macular hole of >400?m diameter in the study eye - High myopia in study eye - Pseudo-exfoliation, Marfan?s syndrome, phacodonesis or any other finding in the Investigator?s opinion suggesting lens/zonular instability. - Therapy with another investigational agent within 30 days prior to Visit 1. - Active, simultaneous enrollment in another ophthalmology clinical study. - Other protocol-defined exclusion criteria may apply |
- Se excluye a las mujeres en edad fértil si están embarazadas, están en período de lactancia o no están de acuerdo en usar métodos anticonceptivos adecuados para evitar el embarazo durante el transcurso del estudio. - Presentan hipersensibilidad a la ocriplasmina o a alguno de los excipientes de JETREA. - Hay presencia o sospecha de infecciones oculares o perioculares. - Hay presencia de membrana epirretiniana (MER) sobre la mácula en el momento inicial. - TVM/AVM amplia > 1500 micrones en el momento inicial. - Antecedentes de vitrectomía en el ojo del estudio. - Antecedentes de fotocoagulación con láser de la mácula en el ojo del estudio. - Algún trastorno ocular concomitante relevante que, en opinión del investigador, podría preverse que empeorara o requiriera intervención quirúrgica durante el período del estudio. - Agujero macular con diámetro > 400 µm en el ojo del estudio. - Miopía elevada en el ojo del estudio - Pseudoexfoliación, síndrome de Marfan, facodonesis o cualquier otro hallazgo que, en opinión del investigador, indique inestabilidad del cristalino/zonular. - Terapia con otro agente de investigación dentro de los 30 días anteriores a la visita 1. - Inscripción activa simultánea en otro estudio clínico oftalmológico. - Pueden aplicarse otros criterios de exclusión definidios en el protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with nonsurgical resolution of focal vitreomacular traction (VMT/sVMA), as determined by Central Reading Center (CRC) SD-OCT evaluation |
Proporción de pacientes con resolución no quirúrgica de la tracción vitreomacular (TVM/AVMs) focal, según se determine mediante evaluación por tomografía TCO-DE en un centro de medida central (Central Reading Center, CRC). |
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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) |
1. Changes in best-corrected visual acuity (BCVA) at distance compared to Baseline 2. Proportion of subjects with closure of macular hole (MH) (if present at baseline) 3. Proportion of subjects with nonsurgical resolution of VMT/sVMA 4. Proportion of subjects experiencing Pars plana vitrectomy (PPV) 5. Change in central foveal thickness compared to Baseline |
1. Cambios en la agudeza visual mejor corregida (Best-Corrected Visual Acuity, BCVA) a distancia en comparación con el valor inicial. 2. Proporción de pacientes con cierre del agujero macular (AM) (si existía en el momento inicial). 3. Proporción de pacientes con resolución no quirúrgica de la TVM/AVMs. 4. Proporción de pacientes que sufre vitrectomía pars plana (VPP). 5. Cambios en el grosor central de la fóvea en comparación con el momento inicial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline, Days 28, 90 and 180 2. Baseline, Days 28, 90 and 180 3. Days 90 and 180 4. Day 180 5. Baseline, Days 28 and 180 |
1. Inicio, Días 28, 90 y 180. 2. Inicio, Días 28, 90 y 180. 3. Días 90 y 180. 4. Día 180. 5. Inicio, Días 28 y 180. |
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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 | No |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 83 |
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 |
Belgium |
Canada |
France |
Italy |
Netherlands |
Portugal |
Germany |
Hungary |
Spain |
Poland |
United Kingdom |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |