The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Condition: Vitrectomy
Intervention: ocriplasmin; ocriplasmin; ocriplasmin; ocriplasmin; ocriplasmin
Intervention description: 125µg ocriplasmin intravitreal injection; 125µg ocriplasmin intravitreal injection; 125µg ocriplasmin intravitreal injection; 125µg ocriplasmin intravitreal injection; 125µg ocriplasmin intravitreal injection
Intervention MeSH terms: Plasminogen; Fibrinolysin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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)
    

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