Vitreomacular Traction Maculopathy
Conditions
Sponsors
ThromboGenics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA i. Male or female patients aged 18 to 80 years inclusive. ii. Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated according to the principal investigator, including: o Macular edema associated with vitreomacular traction (DME, VMTS) o Stage II-III macular hole of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA i. Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (Surface wrinkling is not an exclusion criterion). ii. 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. iii. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes in the study eye. iv. Patients with high myopia or aphakia in the study eye v. Patients with history of,rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment vi. Patients who are considered likely to require intraocular surgery in the study eye for any reason other than vitreomacular traction maculopathy/macular edema in the coming three months. 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 a history of uveitis or significant trauma in the study eye. x. Patients who are currently being treated for glaucoma in the study eye. xi. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months. xii. Intravitreal injection of any drug in the study eye in the previous 6 months or during the study. xiii. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator. xiv. Patients who in the investigators view will not complete all visits and investigations, including the exit visit at 6 months. xv. Patients who have participated in an investigational drug study within the past 30 days. xvi. HgA1c > 9%. xvii. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg). xviii. Patients with a life-expectancy less than 6 months. xix. Patients who have previously participated in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and preliminary efficacy of two doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy;Secondary Objective: None;Primary end point(s): STUDY ENDPOINTS EFFICACY EVALUATIONS/CRITERIA Primary efficacy endpoint · PVD induction preoperatively, i.e. release of vitreomacular traction (assess by OCT) · Ease of induction of PVD at the beginning of vitrectomy (as assessed by operator) Secondary efficacy endpoints · Extent and speed of resolution of macular edema (as assessed by macular thickness on OCT and fluorescein angiogram). · Post-operative best corrected visual acuity (BCVA) at 1, 2 and 4 weeks and 3 and 6 months. SAFETY EVALUATIONS/CRITERIA · Post-operative complications (including worsening visual acuity, worsening macular edema, vitreous hemorrhage, retinal tear or detachments, other reasons for reoperation, inflammation [presence, severity, location]*, IOP alterations, cataract formation*, visual field alterations [based on Goldmann or Humphrey 30-1 perimetry]) · ERG/ VEP/ EOG pre and post injection/surgery. · Fluorescein angiography to assess for leakage from vessels · OCT *According to criteria defined as follows: - for cataract grading, use LOCS III grading system ADDITIONAL EVALUATIONS · Routine laboratory assessments (haematology, clinical chemistry, urinalysis) · Histopathology on ILM/epiretinal membrane samples | — |
Countries
Belgium, United Kingdom
Outcome results
None listed