Microstructural morphological changes of the macula after intravitreal microplasmin for non-surgical treatment of vitreomacular traction syndrome

• Conditions: 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

• Registration Number: EUCTR2009-015516-18-AT
• Lead Sponsor: niv.-Klinik für Augenheilkunde und Optometrie, Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified