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: 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 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of 125 µg intravitreal microplasmin injection in patients with focal vitreomacular adhesion;Secondary Objective: none;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 | — |
Countries
Belgium
Outcome results
None listed