E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Retinal Vein Occlusion |
Oclusión de las venas retinarias |
|
E.1.1.1 | Medical condition in easily understood language |
Retinal Vein Occlusion |
Oclusión de las venas retinarias |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
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 |
Proportion of subjects demonstrating ≥ 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 2 months ] Based on best corrected visual acuity |
Demostrar que CLS-TA supracoroideo (SC) en combinación con aflibercept intravítreo (IVT) es superior a la administración de aflibercept IVT en monoterapia en cuanto a la proporción de sujetos que demuestren una mejoría ≥ 15 letras en la mejor agudeza visual corregida (MAVC) dos meses después del momento basal |
|
E.2.2 | Secondary objectives of the trial |
- Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months ] Based on ETDRS
- Mean change from baseline in central subfield thickness [ Time Frame: 6 months ] Based on spectral domain optical coherence tomography |
Cambio medio respecto del valor basal en la major agudeza visual corregida (periodo de tiempo:6 meses
Cambio medio respecto del valor basal en el grosor del subcampo central (peridodo de tiempo:6 meses)mediante tomografía de coherencia óptica de dominio espectral |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Has a clinical diagnosis of RVO in the study eye •Has a CST of ≥ 300 µm in the study eye •Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye; •Is naïve to local pharmacologic treatment for RVO in the study eye; •Is at least 18 years of age |
Diagnóstico clínico de OVR en el ojo en studio GSC ≥300 µm en el ojo en estudio Puntuación de la MAVC ETDRS ≥ 20 letras leídas y ≤ 70 letras leídas en el ojo en estudio. No haberse sometido a tratamiento farmacológico local previo para la OVR en el ojo en studio Tener al menos 18 años |
|
E.4 | Principal exclusion criteria |
•Any active ocular disease or infection in the study eye other than RVO •Intraocular pressure > 21mmHg in study eye at visit 1 • history of glaucoma, optic nerve head change consistent with glaucoma damage; or ocular hypertension in the study eye requiring more than one medication •Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study •Any evidence of neovascularization in the study eye |
Cualquier enfermedad o infeccion en el ojo en studio que no sea OVR Presion intraocular>21mmHg en el ojo en estudio en la Visita ! Antecedentes de glaucoma, cambio en la cabeza del nervio optico consistente con daño al glaucoma o hypertension ocular en el ojo en estudio que requiera más de una medicación Cualquier enfermedad sistémica incontrolada que, en opinion del investigador, impida la participación en el estudio Cualquier evidencia de neovascularización en el ojo en estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
proportion of subjects demonstrating ≥ 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA at Visit 4 (Month 2). |
proporción de sujetos que demuestren una mejoría ≥ 15 letras en la MAVC ETDRS en la visita 4 (mes 2) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during treatment period |
Durante el periodo de tratamiento |
|
E.5.2 | Secondary end point(s) |
·Mean change from Baseline (Visit 2, Day 0) in BCVA at Visit 4 (Week 8) and Visit 8 (Week 24) ·Mean change from Baseline (Visit 2, Day 0) in CST at Visit 4 (Week 8) and Visit 8 (Week 24) |
cambio medio en la MAVC en la visita 4 (semana 8) y visita 8 (semana 24)respecto del valor basal (visita 2, dia 0) el cambio medio en el GSC enla visita 4(semana8) y visita 8 (semana 24) respecto del valor basal.(visita 2, dia 0) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
during treatment period |
Durante el periodo de tratamiento |
|
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 | 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 | 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 | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
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 |
Austria |
Canada |
Czech Republic |
Denmark |
Germany |
Hungary |
Israel |
Italy |
Korea, Republic of |
Philippines |
Poland |
Portugal |
Slovakia |
Spain |
Taiwan |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |