Patients who require primary pars plana vitrectomy. A sample of vitreous will be taken at beginning of surgery for PK analysis. MedDRA version: 12.1 Level: LLT Classification code 10047644 Term: Vitrectomy
Conditions
Interventions
Product Name: ocriplasmin
Product Code: ocriplasmin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ocriplasmin
CAS Number: 1048016-09-6
Concentration unit: mg/ml milligram(s)/millili
Sponsors
ThromboGenics NV
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: na;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. | — |
Countries
Belgium
Outcome results
None listed