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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ThromboGenics

ClinicalTrials.gov Identifier:

NCT01159665

First received: July 7, 2010

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2010
Last Updated Date	January 30, 2013
Start Date ^ICMJE	July 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2012)	Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. [ Time Frame: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection ] [ Designated as safety issue: No ] Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.
Original Primary Outcome Measures ^ICMJE (submitted: July 8, 2010)	Ocriplasmin activity levels in vitreous samples [ Time Frame: 7 days after ocriplasmin injection ] [ Designated as safety issue: No ] Ocriplasmin activity levels in vitreous samples [ Time Frame: 5-30 minutes after ocriplasmin injection ] [ Designated as safety issue: No ] Ocriplasmin activity levels in vitreous samples [ Time Frame: 31-60 minutes after ocriplasmin injection ] [ Designated as safety issue: No ] Ocriplasmin activity levels in vitreous samples [ Time Frame: 2-4 hours after ocriplasmin injection ] [ Designated as safety issue: No ] Ocriplasmin activity levels in vitreous samples [ Time Frame: 1 day after ocriplasmin injection ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01159665 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: July 8, 2010)	Worsening visual acuity [ Time Frame: baseline ] [ Designated as safety issue: Yes ] Worsening visual acuity [ Time Frame: surgery day ] [ Designated as safety issue: Yes ] Worsening visual acuity [ Time Frame: post-surgery days 1, 14 and 42 ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE (submitted: January 30, 2013)	Time Necessary to Remove the Vitreous From the Eye [ Time Frame: From first start of vitrectomy cutter till the end of core vitrectomy phase ] [ Designated as safety issue: No ] PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Official Title ^ICMJE	An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Vitrectomy
Intervention ^ICMJE	Drug: ocriplasmin 125µg ocriplasmin intravitreal injection Other Name: microplasmin
Study Arm (s)	Experimental: PPV 5-30 minutes after injection Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection Intervention: Drug: ocriplasmin Experimental: PPV 31-60 minutes after injection Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection Intervention: Drug: ocriplasmin Experimental: PPV 2-4 hours after injection Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection Intervention: Drug: ocriplasmin Experimental: PPV 24 hours (+2 hours) after injection Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection Intervention: Drug: ocriplasmin Experimental: PPV 7 days (+1 day) after injection Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection Intervention: Drug: ocriplasmin No Intervention: PPV without injection Control Arm, no ocriplasmin intravitreal injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	38
Completion Date	January 2011
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01159665
Other Study ID Numbers ^ICMJE	TG-MV-010
Has Data Monitoring Committee	No
Responsible Party	ThromboGenics
Study Sponsor ^ICMJE	ThromboGenics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ThromboGenics
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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