E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Age related macular degeneration and either of the following conditions: 1) not responding to 3 intravitreal anti-VEGF injections, or 2) pigment epithelium rip, or 3) massive haemorrhage. |
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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 |
- To compare visual outcome (distance and reading) and foveal fixation (biomicroscopy, microperimetry) of RPE-choroid graft translocation versus intravitreal anti-VEGF therapy at 12 and 24 months. |
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E.2.2 | Secondary objectives of the trial |
- To compare safety of both treatments. - To determine quality of life (VFQ-25 questionnaire). - To demonstrate whether complement factor-H (CFH) polymorphism correlates with visual |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- informed consent - age ≥ 65 years - AMD in combination with either of the following conditions: - visual loss of ≥ 15 letters on the ETDRS chart after 3 anti-VEGF injections, - subfoveal RPE-tear, - massive submacular haemorrhage (i.e. extending beyond the vascular arcades, subfoveal thickness of 1.5 mm (ultrasonography), and no subfoveal red blood. - visual acuity of 20/63 to 20/800. - history or examination must indicate recent (< 3 months) activity of the lesion (i.e. recent haemorrhage, change of lesion compared to previous examination, deterioration of VA, scotoma or metamorphopsia) - myopia < -8 D - clear media to permit fundus photography, FAG, ICG-A and OCT - capable to follow instructions - willing and physically able to complete study visits during at least 12 months - anticoagulant drugs (Coumarin, antiplatelet agents) can be discontinued during 6 weeks
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E.4 | Principal exclusion criteria |
- haemorrhage or PED secondary to: - retinal angiomatous proliferation - aneurysm - CNV associated with high myopia - polypoidal choriodopathy - known hypersensitivity to humanized monoclonal antibodies - current acute ocular or peri-ocular infection - any major surgical procedure (scheduled) within 1 month of study entry not related to this study, cataract surgery excepted. - known serious allergy to fluorescein or indocyanine green dye - significant other ocular disorders affecting visual acuity - immunocompromised - current treatment for active systemic infection
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E.5 End points |
E.5.1 | Primary end point(s) |
- Visual acuity (lines lost or gained on ETDRS chart) at one year after initial treatment. - Foveal fixation - Reading vision (in Austria, Germany and The Netherlands, the Radner chart will be used; in France and Italy the Parinaud chart; in London Jaeger chart) at one year.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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.8.3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 8 |