E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with central retinal vein occlusion (CRVO) |
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E.1.1.1 | Medical condition in easily understood language |
patient suffering from a central retinal vein occlusion have a clot blocking the outflow of the retinal circulation. Consequently, retinal hemorrhages and edema develop, profoundly affecting vision. |
Patiënten die bloedingen en zwelling van het netvlies vertonen als gevolg van een bloedklonter die de terugstroming van het bloeding uit het oog blokkeert. |
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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 |
This study aims at investigating the therapeutic effect of local intravenous administration of ocriplasmin in patients with a central retinal vein occlusion. The primary outcome measure is change in visual acuity after 6 months
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E.2.2 | Secondary objectives of the trial |
- change in central macular thickness after 6 months
- change in surface of non-perfused retina
- number of intravitreal antiVEGF/ corticosteroid treatments during 6 months
- number of retinal laser treatments during 6 months
- intra-/postoperative complications
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients aged over 18 years
• Recent diagnosis of CRVO
• Onset of symptoms <10 days
• Visual acuity < 2/10 in study eye
• Visual acuity >1/10 in fellow eye
• Central macular thickness >250µm and <1000 µm
• Signed informed consent prior to inclusion
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E.4 | Principal exclusion criteria |
• Fluorescein allergy
• Active neovascularization (NVD/NVE/NVI/NVA)
• Eye disease other than CRVO or Cataract decreasing vision
• Use of acetazolamide or other drugs potentially affecting macular edema, including systemic steroids >10mg/d
• History of retinal surgery
• High myopia (> -10D)
• Contraindication for the use of systemic anticoagulant medication
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change in visual acuity |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First analysis: 1 month after treatment of the last enrolled patient
Final analysis: 6 months after the last treatment of the last enrolled patient |
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E.5.2 | Secondary end point(s) |
• Change in central macular thickness
• Change in surface of non-perfused retina
• Change in retinal perfusion times as assessed by fluo angiography
• Number of intra-/postoperative complications
• Number of intravitreal injected antiVEGF/steroids
• Number of additional (postoperative) retinal laser treatments
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
First analysis: 1 month after treatment of the last enrolled patient
Final analysis: 6 months after the last treatment of the last enrolled patient |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.3 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned days | |