Focal Vitreomacular Adhesion MedDRA version: 9.1 Level: LLT Classification code 10051065 Term: Vitreomacular traction syndrome
Conditions
Sponsors
ThromboGenics NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged = 18 2. Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint) 3. BCVA of 20/25 or worse in study eye 4. BCVA of 20/800 or better in the non-study eye 5. Written informed consent obtained from the subject prior to inclusion in the trial 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: 1. 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 2. 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 3. Subjects with macular hole diameter > 400 µm in the study eye 4. Aphakia in the study eye 5. 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). 6. Subjects with history of rhegmatogenous retinal detachment in either eye 7. Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months 8. Subjects who have had laser photocoagulation to the macula in the study eye at any time 9. Subjects with pseudo-exfoliation, Marfan’s syndrome, phacodenesis or any other finding in the investigator’s opinion suggesting lens/zonular instability 10. Subjects who have had a vitrectomy in the study eye at any time. 11. Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure = 26 mm Hg in spite of treatment with anti-glaucoma medication) 12. Subjects who are pregnant, breastfeeding, 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. 13. Subjects who, in the Investigators view, will not complete all visits and investigations 14. Subjects who have participated in an investigational drug trial within the past 30 days 15. Subjects who have previously participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of intravitreal microplasmin 125 µg dose in subjects with focal vitreomacular adhesion.;Secondary Objective: ;Primary end point(s): Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at day 28, as determined by masked Central Reading Center (CRC) OCT evaluation. Any patients that have creation of an anatomical defect (i.e., retinal hole, retinal detachment) that results in loss of vision or that requires additional intervention will not be counted as successes for this primary endpoint. | — |
Countries
Belgium, Czech Republic, Germany, Poland, Spain, United Kingdom
Outcome results
None listed