E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | LLT |
E.1.2 | Classification code | 10066426 |
E.1.2 | Term | Hemiretinal vein occlusion |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007972 |
E.1.2 | Term | Central retinal vein occlusion |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 | 10038907 |
E.1.2 | Term | Retinal vein occlusion |
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 investigate the effect of intravitreal Ozurdex® treatment on the anterior chamber cytokine and growth factor profile after either CRVO or BRVO |
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E.2.2 | Secondary objectives of the trial |
Retinal vessel diameters, retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, anatomic changes in the macula region as assessed with a Spectralis-OCT, angiographic outcomes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: • Male or female, at least 18 years of age. • Ophthalmoscopic evidence of recent BRVO or CRVO (i.e. a history of 3 months or less). • Macular edema secondary to BRVO or CRVO in the study eye sheduled for intravittreal Ozurdex®. • Retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline. • VA decrease attributable to the edema. • Written informed consent has been obtained. • Female patients of childbearing potential must have a negative urine pregnancy test.
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E.4 | Principal exclusion criteria |
Exclusion criteria
Any of the following will exclude a subject from the study:
• Uncontrolled systemic disease • Symptoms of a clinically relevant illness in the 3 weeks before the first study day • Any ocular condition that, in the opinion of the investigator, would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia) • History of glaucoma, aphakia or presence of anterior chamber intraocular lens, active retinal neovascularization, choroidal neovascularization, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study period. • Contraindication to pupil dilation, known allergy, or contraindication to the use of fluorescein. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Intraocular concentrations of cytokines and growth factors
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Retinal vessel diameters, • retrobulbar flow velocities, • best-corrected visual acuity, • macular sensitivity assessed with Microperimetry OPCO, • anatomic changes in the macula region as assessed with a Spectralis-OCT, • alteration in retinal pigment epithelium as assessed with POL-OCT • angiographic outcomes.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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The trial ends 6 months after the initial treatment for the last enrolled 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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |