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

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ClinicalTrials.gov Identifier: NCT01159665
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : January 30, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

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)

Condition or disease Intervention/treatment Phase
Vitrectomy Drug: ocriplasmin Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PPV 5-30 minutes after injection
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
Experimental: PPV 31-60 minutes after injection
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
Experimental: PPV 2-4 hours after injection
Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
Experimental: PPV 24 hours (+2 hours) after injection
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
Experimental: PPV 7 days (+1 day) after injection
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
No Intervention: PPV without injection
Control Arm, no ocriplasmin intravitreal injection



Primary Outcome Measures :
  1. 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 ]
    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.


Other Outcome Measures:
  1. Time Necessary to Remove the Vitreous From the Eye [ Time Frame: From first start of vitrectomy cutter till the end of core vitrectomy phase ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159665


Locations
Belgium
University Hospital Leuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
ThromboGenics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01159665     History of Changes
Other Study ID Numbers: TG-MV-010
First Posted: July 9, 2010    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: December 17, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Temazepam
Fibrinolysin
Plasminogen
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents