E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Macula oedema secondary to branch retinal vein occlusion |
Edema maculare secondario ad occlusione venosa retinica di branca |
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E.1.1.1 | Medical condition in easily understood language |
Blockage of veins in the eye that leads to build up of fluid causing swelling in the the macula.This may lead to damage to the macula which affects your central vision |
Blocco delle vene nell'occhio che porta alla formazione di liquidi che causano gonfiore nella macula. Questo causa danni alla macula che colpisce la visione centrale |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025415 |
E.1.2 | Term | Macular oedema |
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 compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO |
Confrontare l’efficacia e la sicurezza di Ozurdex vs. Lucentis in soggetti affetti da BRVO |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, ≥ 18 years of age 2. Written informed consent has been obtained 3. Written Data Protection Consent (European sites only) has been obtained 4. Study eye must have clear ocular media and adequate pupil dilation to permit good quality photographic imaging 5. ME secondary to BRVO in the study eye with all of the following characteristics: a) involving the centre of the macula (fovea) b) central retina subfield thickness ≥ 320 μm as assessed with Spectralis optical coherence tomography (OCT) or ≥ 300 μm as assessed with Cirrus OCT c) less than 90 days from onset of BRVO symptoms to screening visit d) visual acuity (VA) decrease attributable to retinal oedema Note: Characteristics a and b will be confirmed by a CRC 6. Absence of severe macular ischemia (defined as an area of nonperfusion > 4 disc areas [DA] which involve the foveal avascular zone), as confirmed by a CRC 7. BCVA score of ≥ 20 to ≤ 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol at both the screening visit and day 1 visit. 8. Female subjects of childbearing potential must have a negative urine pregnancy test at the screening (day -14) visit |
1.Uomini o donne di eta' ≥ 18 anni 2.Consenso informato scritto 3.Consenso scritto alla protezione dei dati personali 4.Occhio con la media oculare chiara e adeguata dilatazione della pupilla per permettere una buona qualita' delle immagini fotografiche 5.EM secondaria a BRVO nell`occhio in studio con tutte le seguenti caratteristiche: a) coinvolgimento del centro della macula (fovea) b) Spessore medio retinico centrale ≥ 320 μm rilevato con Spectralis OCT (Heidelberg) o ≥ 300 μm rilevato con Cirrus OCT (Carl Zeiss).c) meno di 90 giorni dalla comparsa dei sintomi BRVO alla visita di screening d) la diminuzione dell’acuita' visiva (VA) attribuibile ad edema retinico Nota: le caratteristiche a e b saranno confermata da un CRC 6.Assenza di grave ischemia maculare (definita come una zona di non perfusione > 4 aree del disco che coinvolgono la zona foveale avascolare), come confermato da un CRC 7.Punteggio BCVA da ≥ 20 a ≤ 70 lettere (20/40 a 20/400 equivalente Snellen) utilizzando lo studio Trattamento precoce per la retinopatia diabetica (ETDRS) protocollo sulla acuita' visiva sia alla visita di screening che alla visita giorno 1. 8.Soggetti di sesso femminile in eta' fertile devono avere un test di gravidanza sulle urine alla visita di screening (giorno -14) |
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E.4 | Principal exclusion criteria |
1.History of a medical condition that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of study medication. 2.Ocular hypertension unless controlled with monotherapy. 3.Pregnant or nursing (lactating) women, 4.Pre-menopausal women of child-bearing potential not using adequate Contraception. 5.Participation in an investigational drug or device study within 30 days of the screening visit. 6.Any current or history of ocular disease in the study eye other than RVO that, in the opinion the investigator, may confound assessment of the macula or affect central vision, such as exudative age-related macular degeneration, geographic atrophy, diabetic retinopathy, uveitis, streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole, or significant cataract 7.History of cataract surgery in either eye within the past 3 months prior to the screening visit 8.History or evidence of serious ocular trauma or intraocular surgery (such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy) in the study eye within the past 6 months prior to the screening visit 9.History of severe or serious hypersensitivity to any components of the test article or fluorescein dye. 10.> 10-Letter improvement in BCVA between the screening visit and day 1 11.Brisk afferent pupillary defect (ie, obvious and unequivocal) 12.Aphakia in the study eye or violation of the posterior capsule in the study eye, unless it occurred as a result of a yttrium-aluminum-garnet laser posterior capsulotomy in association with prior, posterior intraocular lens implantation 13.Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in adnexa of either eye 14.History of radial optic neurotomy or sheathotomy 15.Laser photocoagulation for ME in the study eye within 3 months prior to the screening visit 16.Anticipated need for ocular surgery or ophthalmic laser treatment in the study eye during the 12-month study period 17.Prior anti-VEGF treatment in study or fellow eye within 3 months of screening or systemic anti-VEGF treatment within 6 months of the screening visit 18.Use of intraocular, intravitreal, or peri-ocular steroids in the study eye within 3 months of the screening visit 19.Use of systemic steroids (eg, oral, intravenous, intra-articular, epidural, intrabursal) within 1 month of screening or anticipated use at any time during the study. Inhaled and intranasal steroids are allowed. 20.IOP > 22 mm Hg at screening or day 1 visit in either eye. |
Storia di una condizione clinioca che, a giudizio dello sperimentatore, precluderebbe in le visite dellostudio, il completamento dello studio, o la somministrazione sicura del farmaco in studio. Ipertensione oculare controllata meno con monoterapia. 3.Donne in gravidanza o in allattamento 4.Donne in eta' fertile in pre-menopausa che non usano contraccettivi adeguati. 5.Participatione a un farmaco sperimentale o dispositivo medico 30 giorni prima la visita di screening. 6. Qualsiasi storia clinica in corso o passata di malattia oculare negli occhio RVO diverso da quello che, a giudizio del ricercatore, poptrebbe confondere la valutazione della macula o influire la visione centrale, come essudativa legata all`eta' della degenerazione maculare, atrofia geografica, retinopatia diabetica, uveite, striature, istoplasmosi, miopia patologica, distacco di retina, membrana epiretiniche, foro maculare, o significativa cataratta 7.Intervento chirurgico di cataratta in entrambi gli occhi negli ultimi 3 mesi prima della visita di screening 8.Storia clinica o evidenza di traumi oculari gravi o interventi chirurgici intraoculare (come il laser-assistita in situ cheratoplastica, vitrectomia) nell`occhio in studio negli ultimi 6 mesi precedenti la visita di screening 9.Storia di ipersensibilita' grave o seria ai principi del farmaco in studio o al colorante fluoresceina. 10.> 10-Lettera miglioramento BCVA tra la visita di screening e giorno 1 11. Difetto alla pupillare (ad esempio, evidente e inequivocabile) 12. Afachia nell`occhio in studio o violazione della capsula posteriore nell`occhio in studio, a meno che non sia verificato come risultato di capsulotomia posteriore in associazione con la prima, impianto di lente intraoculare posteriore 13. Qualsiasi infezione oculari attive (batteriche, virali,parassitarie o fungine) 14. Storia di neurotomia ottica radiale o di guainotomia. 15.Fotocoagulazione per ME nell`occhio in studio entro 3 mesi prima della visita di screening 16.Anticipata la necessita' di un intervento oculare chirurgico o trattamento laser oftalmico nell`occhio in studio durante il periodo di 12 mesi dello studio 17.Anti-VEGF trattamento entro 3 mesi dallo screening o o trattamento sistemico anti VEGF trattamento entro 6 mesi dalla visita di screening 18.Uso di intraoculare, intravitreali, o peri-oculare steroidi nell`occhio in studio entro 3 mesi dalla visita di screening 19. Uso di steroidi per via sistemica (ad esempio, orale, endovenosa, intra-articolare, epidurale) entro 1 mese dallo screening o in qualsiasi momento durante lo studio. Sono ammessi steroidi per via inalatoria e intranasale. 20.IOP> 22 mm Hg allo screening o al giorno 1 in ciascun occhio |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is mean change in BCVA at month 12. |
Variabile primaria di efficacia e' la variazione media in BCVA al 12 mese |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
BCVA assessment at screening, baseline, day 7 and at each monthly visit |
Valutazione BCVA allo screening, al basale, al giorno 7 e ad ogni visita mensile |
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E.5.2 | Secondary end point(s) |
1.Mean change in the central retina subfield thickness between baseline and month 6, and between baseline and month 12 2. Proportion of subjects with ≥ 15-letter improvement in BCVA between baseline and month 12 3. Proportion of subjects with ≥ 15-letter decrease in BCVA between baseline and month 12 4. Change from baseline in vision-dependent subfields of the VFQ-25 questionnaire including near vision, far vision, and vision-dependent activity at month 3, month 6, and month 12. 5. Proportion of subjects in each treatment arm not completing the month 12 visit due to treatment failure. Treatment failure is defined as a subject withdrawn by the investigator prior to the final visit because of a lack of efficacy. |
Variazione media nello spessore medio retinico centrale tra il basale e il mese 6, e tra il basale e il mese 12 Percentuale di soggetti con miglioramento ≥ di 15-lettera in BCVA tra il basale e il mese 12 Percentuale di soggetti con ≥ diminuzione di 15 lettere di BCVA tra il basale e il mese 12 Cambiamento dal basale nei sottocampi visione dipendente del questionario VFQ 25 compresa la visione da vicino, visione lontana, la visione e l`attivita'-dipendente al mese 3, al mese 6 e al mese 12 Percentuale di soggetti che hanno interrotto il trattamento per scarsa efficacia in entrambi i bracci prima del 12 mese. Per fallimento del trattamento si intende un soggetto ritirato dallo sperimentatore prima della visita finale a causa di una mancanza di efficacia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. OCT assessments that will be used in evaluation of timepoint will be done at baseline, month 6 and month 12. 2. and 3. BCVA assessments that will be used in evaluation of timepoints will be done at baseline and month 12. 4. VFQ-25 questionnaire completed at baseline, month 3, month 6, and month 12. |
1. Valutazioni OCT che saranno utiliizzati per la valutazione dei timepoint che saranno eseguiti alla visita basale, mese 6 e mese 12 2. e 3. Valutazioni BCVA che veranno utilizzate per la valutazione dei tempi che saranno eseguiti alla visita basale e mese 12. 4. VFQ-25 questionario compilato al basale, mese 3, mese 6 e mese 12 |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | 34 |
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 |
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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 | 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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |