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

NCT ID: NCT01159665

Last Updated: 2014-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-01-31

Brief 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)

Detailed 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.

Conditions

Vitrectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PPV 5-30 minutes after injection

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

Group Type: EXPERIMENTAL

ocriplasmin

Intervention Type: DRUG

125µg ocriplasmin intravitreal injection

PPV 31-60 minutes after injection

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

Group Type: EXPERIMENTAL

ocriplasmin

Intervention Type: DRUG

125µg ocriplasmin intravitreal injection

PPV 2-4 hours after injection

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

Group Type: EXPERIMENTAL

ocriplasmin

Intervention Type: DRUG

125µg ocriplasmin intravitreal injection

PPV 24 hours (+2 hours) after injection

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

Group Type: EXPERIMENTAL

ocriplasmin

Intervention Type: DRUG

125µg ocriplasmin intravitreal injection

PPV 7 days (+1 day) after injection

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

Group Type: EXPERIMENTAL

ocriplasmin

Intervention Type: DRUG

125µg ocriplasmin intravitreal injection

PPV without injection

Control Arm, no ocriplasmin intravitreal injection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ocriplasmin

125µg ocriplasmin intravitreal injection

Intervention Type: DRUG

ocriplasmin

125µg ocriplasmin intravitreal injection

Intervention Type: DRUG

ocriplasmin

125µg ocriplasmin intravitreal injection

Intervention Type: DRUG

ocriplasmin

125µg ocriplasmin intravitreal injection

Intervention Type: DRUG

ocriplasmin

125µg ocriplasmin intravitreal injection

Intervention Type: DRUG

Other Intervention Names

microplasmin; microplasmin; microplasmin; microplasmin; microplasmin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThromboGenics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Leuven

Leuven, , Belgium

Countries

Belgium

References

Stalmans P, Girach A. Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial. Invest Ophthalmol Vis Sci. 2013 Oct 9;54(10):6620-7. doi: 10.1167/iovs.13-11811.

Reference Type: DERIVED

PMID: 23982845 (View on PubMed)

Other Identifiers

TG-MV-010

Identifier Type: -

Identifier Source: org_study_id