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

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.

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