The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV) (MIVI-10)

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Vitrectomy

Treatments: Drug: ocriplasmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01159665

TG-MV-010

Details and patient eligibility

About

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)

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 6 patient groups

PPV 5-30 minutes after injection

Experimental group

Description:

Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

PPV 31-60 minutes after injection

Experimental group

Description:

Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

PPV 2-4 hours after injection

Experimental group

Description:

Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

PPV 24 hours (+2 hours) after injection

Experimental group

Description:

Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

PPV 7 days (+1 day) after injection

Experimental group

Description:

Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

Drug: ocriplasmin

PPV without injection

No Intervention group

Description:

Control Arm, no ocriplasmin intravitreal injection