E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 | 10051065 |
E.1.2 | Term | Vitreomacular traction syndrome |
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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 efficacy of 125 μg intravitreal microplasmin injection in patients 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 |
I. Male or female patients aged >= 18 II. Presence of focal vitreomacular adhesion (ie, central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex III. BCVA of 20/32 or worse in the study eye IV. BCVA of 20/400 or better in the contralateral eye V. Written informed consent obtained from the patient prior to inclusion in the study |
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E.4 | Principal exclusion criteria |
I. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection II. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye III. Patients with vitreous hemorrhage 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 angiogram in the study eye IV. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes. V. Patients with high myopia (> 8D) or aphakia in the study eye. VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye VII. Patients who have had ocular surgery in the study eye in the prior three months VIII. Patients who have had a vitrectomy in the study eye at any time. IX. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months XI. Intravitreal injection of any drug in the study eye in the previous 3 months XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last visit at 6 months after the last injection XIV. Patients who have participated in an investigational drug study within the past 30 days XV. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg) XVI. Patients with a life expectancy less than 6 months XVII. Patients who have previously participated in this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints Post-injection complications (including worsening visual acuity, change in vision, worsening macular edema, vitreous hemorrhage, retinal tear or detachments, inflammation, IOP alterations.
Safety Assessments History/full ophthalmologic examination (including full retinal examination): baseline, post-injection days 7, 14 and 28 and months 3 and 6 Fluorescein Angiography: baseline and 6 months Fundus Photography: baseline and 6 months Full-field Electroretinography (ERG)*: baseline, post injection day 7 Visual Evoked Potential (VEP)*: baseline, post injection day 7 Visual Field test (Humphrey 24-2 and Goldmann Perimetry)*: baseline, post injection day 7 Color Arrangement test (Roth 28-Hue test)*: baseline, post injection day 7
* If the outcome of these tests is significantly worsened compared to baseline, these tests should be repeated at subsequent visit(s) until resolved.
Primary Efficacy Endpoint Proportion of patients with non surgical resolution vitreomacular adhesion at the 28 day visit.
Secondary Efficacy Endpoints Proportion of patients with nonsurgical resolution of focal vitreomacular adhesion at study visits other than the 28 day post-injection visit Proportion of patients with total PVD induction Proportion of patients requiring additional treatment (vitrectomy) ME resolution (change from baseline in macular thickness in the central subfield) Change in BCVA Achievement of > 2 and > 3 lines improvement in BCVA without need for alternative therapy (i.e. intravitreal drug injection, laser photocoagulation, or vitrectomy) and time to > 2 and > 3 lines improvement in BCVA without need for vitrectomy 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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |