E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Macular oedema related to retinal vascular diseases |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025415 |
E.1.2 | Term | Macular oedema |
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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 evaluate the rate of change of macular oedema with intravitreal ozurdex injections in patients with macular oedema |
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E.2.2 | Secondary objectives of the trial |
Will re-treatment based on recurrence of oedema and decline in vision give better efficiacy outcomes with no new safety concerns? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged 18 or above 2. Ability to provide informed consent 3. Diagnosis of macular oedema secondary to diabetic maculopathy, branch and central retinal vein occlusion or pseudophakic cystoid macular oedema or post inflammatory macular oedema 4. Central macular thickness on OCT should be above 250µm 5. Best corrected visual acuity in the study eye between 37 and 68 letters
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E.4 | Principal exclusion criteria |
1. Any other eye disease which could mask macular oedema 2. Known uncontrolled systemic disease or current immunosuppressive disease. 3. Initiation of medical therapy for diabetes or a change from oral hypoglycaemic agents to insulin therapy within 4 months prior to the screening visit 4. Renal failure requiring haemodialysis or peritoneal dialysis within 6 months prior to screening visit 5. Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy) 6. Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular oedema, or is severe enough to prevent improvement in visual acuity despite reduction in macular oedema 7. Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. 8. Advanced glaucoma which cannot be adequately controlled by medicinal products alone. 9. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) >10 mm Hg increase in IOP from baseline with an absolute IOP > 25 mm Hg b) required therapy with 3 or more anti-glaucoma medications
10. Pregnancy if child bearing age (confirmed by pregnancy test) and to avoid pregnancy during the 36 weeks of the study. Pregnancy test will not be done in post-menopausal women (defined as 12 months post LMP). Breast feeding women will be excluded. 11. Hypersensitivity to the active substance or to any of the excipients. 12. Inability to provide informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change in OCT at 4 weekly time points |
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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.8.3 |
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 | 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
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Last patient's last visit |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |