E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with exudative AMD with focal vitreomacular adhesion |
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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 | 10015902 |
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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 | 10051065 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060823 |
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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 safety and preliminary efficacy of intravitreal microplasmin in subjects with exudative AMD with focal vitreomacular adhesion |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. Male or female subjects aged > 50 . Presence of focal vitreomacular adhesion with a central retinal thickness of at least 250 �m as measured by OCT . Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component . The total area of CNV (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area . The total lesion area must be < 12 disc areas . Subjects who have previously received at least three Lucentis injections in the study eye . Subjects with visual acuity of 20/40 to 20/200 in the study eye . Written informed consent obtained from the subject prior to inclusion in the study |
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E.4 | Principal exclusion criteria |
. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection . Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus . Subjects who have previously received more than 6 Lucentis injections in the study eye . Subjects with history of rhegmatogenous retinal detachment or PVR in the study eye . Subjects with high myopia (> 8D) or aphakia in the study eye . Subjects who have had ocular surgery in the study eye in the prior three months . Subjects who have had a vitrectomy in the study eye at any time . Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure > 26 mm Hg in spite of treatment with anti-glaucoma medication) .Intravitreal injection of any drug or photodynamic therapy in the study eye in the previous 10 days or such planned treatment in the 10 days following study drug injection .Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide. . Subjects who, in the investigators view, will not complete all visits and investigations . Subjects who have participated in an investigational drug study within the past 30 days . Subjects who have received an anti-anti-angiogenic agent Intravitreal injection other than Lucentis in the study eye within the past 30 days, or in whom anti-angiogenic agent Intravitreal injection other than Lucentis is foreseen during the trial period . Subjects who have previously participated in this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoint �� History/full ophthalmologic examination (including dilated biomicroscopy, ophthalmoscopy, OCT): baseline, postinjection days 7, 14 and 28 and post-injection months 3, 6 and 12. �� Fundus Photography: baseline, day 28 and 12 months postinjection �� Fluorescein angiography: baseline, day 28 and 12 months post injection Primary Efficacy Endpoint �� Proportion of subjects with release of focal vitreomacular adhesion by day 28 as determined by masked Central Reading Center evaluation of imaging (OCT) Secondary Efficacy Endpoints �� Vitreomacular adhesion status and PVD status at visits other than day 28 post-injection visit (OCT and ultrasound) �� Visual Acuity (ETDRS) �� Central retinal/lesion thickness (OCT) �� Membrane growth: evaluated by OCT (Spectral Domain where available) and fluorescein-angiography �� Size of fluorescein leakage �� Number of subjects requiring additional therapy �� Number of Lucentis injections required during the study �� Initial Lucentis free interval �� VFQ-25 |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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definizione della conclusione della sperimentazione = ultima visita dell`ultimo soggetto inserito nella sperimentazione. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |