E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreomacular Traction Maculopathy |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and preliminary efficacy of four doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 < 6 months duration since symptom onset iii Demonstration of vitreomacular adhesion (based on preoperative OCT) in the study eye o OCT - presence of posterior hyaloid membrane inserting on to the macula, but with some area of clear separation visible between the retina and the posterior hyaloid iv Written informed consent obtained from the patient prior to inclusion in the study
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject, unless the Safety Committee recommends premature termination of the trial as a result of safety concerns. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |