E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who require primary pars plana vitrectomy. A sample of vitreous will be taken at beginning of surgery for PK analysis. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047644 |
E.1.2 | Term | Vitrectomy |
|
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 pharmacokinetic properties of intravitreal ocriplasmin 125 ug dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV) |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects aged ≥ 18 • Eye disease for which a primary vitrectomy is indicated • BCVA of 20/800 or better in the non-study eye • Written informed consent obtained from the subject prior to inclusion in the trial
|
|
E.4 | Principal exclusion criteria |
• Proliferative diabetic retinopathy. • 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 • Aphakia in the study eye • 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). • Subjects with history of rhegmatogenous retinal detachment in the either eye • Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months • Subjects who have had laser photocoagulation to the macula in the study eye at any time • Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 26 mm Hg in spite of treatment with anti-glaucoma medication) • Subjects with a history of uveitis in either eye. • Subjects who are pregnant 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. • Subjects who, in the Investigators view, will not complete all visits and investigations • Subjects who have participated in an investigational drug trial within the past 30 days • Subjects who have previously participated in this trial
|
|
E.5 End points |
E.5.1 | 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)
- Primary Outcome Endpoint (PK) Ocriplasmin activity levels in vitreous samples obtained at the beginning of vitrectomy (5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection)
- Efficacy Endpoint Time necessary to remove the vitreous from the eye measured from first start of vitrectomy cutter till end of core vitrectomy phase.
|
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
no ocriplasmin injection prior to pars plana vitrectomy |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
The end of the trial is defined as the last visit of the last subject. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |