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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThromboGenics
• Treatments: Fibrinolysin; Plasminogen; Temazepam

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