E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreomacular traction syndrome (VMTS) is a distinct clinical entity characterized by an incomplete separation of the posterior vitreous surface from the retina with persistent posterior hyaloid adhesion at the macula causing traction-induced visual deficits |
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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 |
In the current study we hypothesize that functional outcomes assessed with BCVA, multifocal ERG and Microperimetry Nidek MP1 in response to microplasmin treatment is correlated to changes in microstructure of macula and vitreomacular interface assessed with high-definition three dimensional OCT after three months. |
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E.2.2 | Secondary objectives of the trial |
There is almost no literature about cytokine alterations in ocular fluids of patients with VMTS and there is no data about how they are altered by microplasmin therapy. Recent developments in proteome analysis have facilitated the analysis of protein profiles. With the increased sensitivity, resolution, and enhancements in mass-spectrometry, it is now possible to evaluate the entire protein profile of ocular fluids. Employing mass spectrometry, only a few studies have investigated human aqueous and viteous. The combination of this method to screen for divergent protein expression profiles with multiplex bead arrays to determine and quantify specific proteins enables an extensive evaluation of protein profiles of ocular fluid. The analysis of ocular fluid from patients with VMTS might lead to the identification of new proteins for therapy efficiency. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female, at least 18 years of age. - ophthalmoscopic and OCT evidence of VMTS, that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint) - BCVA of 20/25 or worse in study eye - BCVA of 20/800 or better in the non-study eye - written informed consent obtained from the subject prior to inclusion in the trial - female patients of childbearing potential must have a negative urine pregnancy test.
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E.4 | Principal exclusion criteria |
Any of the following will exclude a subject from the study: - Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye - Subjects with any vitreous hemorrhage or any other vitreous opacification 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 - Subjects with full thickness macular hole in the study eye - Aphakia in the study eye - High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion). - Subjects with history of rhegmatogenous retinal detachment in either eye - Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months - Subjects who have had laser photocoagulation to the macula in the study eye at any time - Subjects with pseudo-exfoliation, Marfan’s syndrome, phacodenesis or any other finding in the investigator’s opinion suggesting lens/zonular instability - Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 26 mm Hg in spite of treatment with anti-glaucoma medication) - 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 trial within the past 30 days - Subjects who have previously participated in this trial
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E.5 End points |
E.5.1 | Primary end point(s) |
• To investigate the morphological and functional treatment effect of intravitreal microplasmin in patients with VMTS and to correlate the morphological changes with changes in functional outcomes during 12 weeks follow-up time. • To investigate protein levels in VMTS (including inflammatory cytokines and growth factors: EGF, FGF, VEGF, IFNg, IL-4, IL-6, IL-8, IL-10, MCP-1, PDGF, TNF-a, ICAM; proteom analysis)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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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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 | |
E.8.9.1 | In the Member State concerned days | |