Clinical trial NCT01159665: The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Official title: An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitrectomy
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)

Detailed description: Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).

Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged ≥ 18
* Eye disease for which a primary vitrectomy is indicated
* Best Corrected Visual Acuity (BCVA) of 20/800 or better in the non-study eye
* Written informed consent obtained from the subject prior to inclusion in the trial

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 Optical Coherence Tomography (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

Primary outcomes:
measure: Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.
timeFrame: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
Secondary outcomes:
Other outcomes:
measure: Time Necessary to Remove the Vitreous From the Eye
timeFrame: From first start of vitrectomy cutter till the end of core vitrectomy phase
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References:
citation: Stalmans P, Girach A. Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial. Invest Ophthalmol Vis Sci. 2013 Oct 9;54(10):6620-7. doi: 10.1167/iovs.13-11811.