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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitrectomy

Intervention / Treatment
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* Drug: ocriplasmin
* Drug: ocriplasmin
* Drug: ocriplasmin
* Drug: ocriplasmin
* Drug: ocriplasmin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPV 5-30 minutes after injection<br>Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection | Drug: ocriplasmin<br>* 125µg ocriplasmin intravitreal injection<br>* Other names: microplasmin;|
| Experimental: PPV 31-60 minutes after injection<br>Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection | Drug: ocriplasmin<br>* 125µg ocriplasmin intravitreal injection<br>* Other names: microplasmin;|
| Experimental: PPV 2-4 hours after injection<br>Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection | Drug: ocriplasmin<br>* 125µg ocriplasmin intravitreal injection<br>* Other names: microplasmin;|
| Experimental: PPV 24 hours (+2 hours) after injection<br>Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection | Drug: ocriplasmin<br>* 125µg ocriplasmin intravitreal injection<br>* Other names: microplasmin;|
| Experimental: PPV 7 days (+1 day) after injection<br>Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection | Drug: ocriplasmin<br>* 125µg ocriplasmin intravitreal injection<br>* Other names: microplasmin;|
| No Intervention: PPV without injection<br>Control Arm, no ocriplasmin intravitreal injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. | 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. | 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection |