E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Central retinal vein occlusion |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007972 |
E.1.2 | Term | Central retinal vein occlusion |
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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 |
visual acuity changes at 6 months |
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E.2.2 | Secondary objectives of the trial |
proportion of patients with visual acuity of 20/40 or more change in macular edema at 6 months occurence of complications of retinal vein occlusion occurence of side effects of the treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Occlusion de la veine centrale de la rétine confirmée par une angiographie à la fluorescéine - Age de 18 à 75 ans - Acuité visuelle inférieure ou égale à 20/32 (6/10) - Durée d’évolution de l’occlusion veineuse de moins de 3 semaines - Bon accès au fond de l’œil - Patient possédant un hématocrite inférieur ou égal à 38 % - Patient informé des objectifs de l’étude et ayant signé la lettre de consentement éclairé |
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E.4 | Principal exclusion criteria |
-Complication néovasculaire dans l’œil étudié -OVCR avec ischémie étendue nécessitant un traitement urgent au laser -Autre lésion rétinienne ou choroïdienne dans l’œil étudié, ou problème oculaire autre (glaucome avancé, rétinopathie diabétique etc…) -Œil étudié déjà traité par laser, chirurgie rétino-vitréenneenne, IVT -Impossibilité de mesurer de manière fiable l'acuité visuelle ou l'épaisseur maculaire -Membrane épi-maculaire symptomatique dans l’œil étudié -Infection de l’œil ou de ses annexes -Diabète, avec ou sans rétinopathie diabétique -HTA ou pathologie cardio-vasculaire non équilibrée -Grossesse -Absence prévisible de compliance au protocole -Accident vasculaire cérébral ou cardiaque récent de moins de 3 mois -Allergie connue au médicament utilisé |
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E.5 End points |
E.5.1 | Primary end point(s) |
change in visual acuity at 6 months |
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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 | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
Inclusion of 45 patients, follow-up of 6 months The end of the trial is the last visit of the last patient. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |