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: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Vitrectomy
Drug: ocriplasmin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 38
Study Start Date: July 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159665

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

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01159665     History of Changes
Other Study ID Numbers: TG-MV-010
Study First Received: July 7, 2010
Results First Received: December 20, 2012
Last Updated: April 4, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on August 28, 2014