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
Conditions
Sponsors
Univ.-Klinik für Augenheilkunde und Optometrie, Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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) | — |
Countries
Austria
Outcome results
None listed