E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Retinal Vein Occlusion |
Occlusione venosa retinica |
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E.1.1.1 | Medical condition in easily understood language |
Retinal Vein Occlusion |
Occlusione venosa retinica |
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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 | LLT |
E.1.2 | Classification code | 10030009 |
E.1.2 | Term | Occlusion retinal vein |
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 |
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 |
¿ La proporzione di soggetti che dimostrano un miglioramento della miglior acuit¿ visiva corretta (Best Corrected Visual Acuity, BCVA) =15 lettere due mesi dopo il baseline (valore basale). [ Time Frame: 2 mesi] Sulla base della migliore acuit¿ visiva corretta |
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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
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¿ La variazione media di BCVA dal baseline sulla base della migliore acuit¿ visiva corretta [ Time Frame: 6 mesi ] Sulla base del ETDRS ¿ La variazione media dello spessore dell'area centrale dell'occhio dal baseline [ Time Frame: 6 mesi ] Sulla base dell'esame: "spectral domain optical coherence tomography"
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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
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• Ha ricevuto una diagnosi clinica di RVO nell'occhio in studio • Ha un CST di = 300 micron nell'occhio in studio • Ha un punteggio BCVA ETDRS compreso tra 20 e 70 lettere lette con l'occhio in studio; • è naive a trattamento farmacologico locale per RVO nell'occhio in studio; • ha almeno 18 anni di età |
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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
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• Qualsiasi malattia oculare attiva o infezione nell'occhio di studio diversa da RVO • Pressione intraoculare > 21mmHg nell'occhio di studio alla visita 1 • Storia di glaucoma, cambiamenti nella testa del nervo ottico coerenti con i danni del glaucoma; oppure ipertensione oculare nell'occhio di studio che richiede più di un farmaco per la cura • Qualsiasi malattia sistemica non controllata che, a giudizio dello sperimentatore, potrebbe precludere la partecipazione allo studio • Qualsiasi evidenza di neovascolarizzazione nell'occhio di studio |
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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). |
La proporzione di soggetti che dimostrano un miglioramento di =15 lettere dal baseline nello studio del trattamento precoce della retinopatia diabetica alla visita 4 (mese 2) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during treatment period |
durante il periodo di trattamento |
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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) |
¿ Variazione media dalla baseline (Visita 2, giorno 0) in BCVA alla Visita 4 (Settimana 8) e visita 8 (settimana 24) ¿ Variazione media dalla baseline (Visita 2, giorno 0) in CST alla Visita 4 (Settimana 8) e visita 8 (settimana 24) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
during treatment period |
durante il periodo di trattamento |
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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 | 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 | 7 |
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 | 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 |
Australia |
Canada |
Israel |
Korea, Republic of |
Philippines |
Taiwan |
United States |
Austria |
Czechia |
Denmark |
Germany |
Italy |
Poland |
Portugal |
Slovakia |
Spain |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
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 |