Vitreomacular Traction Syndrome MedDRA version: 8.1 Level: LLT Classification code 10051065 Term: Vitreomacular traction syndrome
Conditions
Interventions
Product Name: Microplasmin
Product Code: M-PLA-P08-REC-FOR/1.875-a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Microplasmin
Current Sponsor code: M-PLA-P08-REC-FOR/1.875-a
Concent
Sponsors
ThromboGenics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I. Male or female patients aged >= 18 II. Patients with a partial central PVD, but with vitreous still attached on the foveal area (documented on OCT and/or ultrasound) causing secondary macular edema (>= 250 µm in either the central subfield on OCT or measured on one of the individual radial scans of the macular area) III. No evidence in either eye of complete macular PVD (on biomicroscopy, B-scan or OCT), i.e. attached posterior hyaloid or incomplete PVD with vitreomacular adhesions IV. BCVA of 20/40 or worse in study eye V. BCVA of 20/400 or better in the contralateral eye VI. 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 (axial length > 26.0 mm on A-scan ultrasound) 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 double-masked visit at 6 months 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 preliminary efficacy of 4 doses of intravitreal microplasmin in patients with vitreomacular traction;Secondary Objective: None;Primary end point(s): Primary efficacy endpoint: Proportion of patients with total PVD (ie, vitreous detachment to the equator) as determined by masked Central Reading Center evaluation of the day 14 visit imaging after each injection (4-quadrant B-scan and OCT) Secondary efficacy endpoints: • Proportion of patients with total PVD as determined by masked Central Reading Center evaluation of imaging (4-quadrant US and OCT) from study visits other than the day 14 post-injection visit after each injection • Proportion of patients requiring additional treatment (vitrectomy) • ME resolution (change from baseline in macular thickness in the central subfield; central foveal thickness [mean thickness at the point of intersection of the 6 radial scans]; and macular volume on OCT) • 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 Safety Evaluations / Criteria: The safety profile of the different treatment regimens will be assessed based on: I. Post-injection complications (including worsening visual acuity, worsening macular edema, vitreous hemorrhage, retinal tear or detachments, inflammation [presence, severity, location]*, IOP alterations, cataract formation* II. Fluorescein angiography to assess for leakage from vessels III. OCT *According to criteria defined as follows: - for anterior chamber and vitreous inflammation grading, use scales defined in Appendix 6 of the protocol - for cataract grading, use LOCS III grading system | — |
Countries
Belgium
Outcome results
None listed