The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)

Phase 2

Completed

Conditions: Vitrectomy

Interventions: Drug: ocriplasmin

Registration Number: NCT01159665

Lead Sponsor: ThromboGenics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPV 31-60 minutes after injection	ocriplasmin	Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection
PPV 7 days (+1 day) after injection	ocriplasmin	Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection
PPV 5-30 minutes after injection	ocriplasmin	Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection
PPV 2-4 hours after injection	ocriplasmin	Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection
PPV 24 hours (+2 hours) after injection	ocriplasmin	Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection

Primary Outcome Measures

Name	Time	Method
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	Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 \[5-30 minutes\]; Group 2 \[31-60 minutes\]; Group 3 \[2-4 hours\]; Group 4 \[24 hours ±2 hours\]; Group 5 \[7 days ±1 day\]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.

Secondary Outcome Measures