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
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Vitrectomy
Intervention: Drug: ocriplasmin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was enroled on 15 Jul 2010 and the last patient completed the study opn 30 Nov 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

38 subjects were enrolled into the study. However, the vitreous samples for 2 subjects were excluded from the analysis:

  • The vitreous sample for Subject 101106 was contaminated during vitrectomy.
  • Subject 101202 (Group 2) had a previous vitrectomy and retinal detachment in the study eye (exclusion criteria violation).

Reporting Groups
  Description
PPV 5-30 Minutes After Injection Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
PPV 31-60 Minutes After Injection Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
PPV 2-4 Hours After Injection Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
PPV 24 Hours (+2 Hours) After Injection Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
PPV 7 Days (+1 Day) After Injection Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
PPV Without Injection Control Arm, no ocriplasmin intravitreal injection

Participant Flow:   Overall Study
    PPV 5-30 Minutes After Injection     PPV 31-60 Minutes After Injection     PPV 2-4 Hours After Injection     PPV 24 Hours (+2 Hours) After Injection     PPV 7 Days (+1 Day) After Injection     PPV Without Injection  
STARTED     9     9     8     4     4     4  
COMPLETED     9     8     8     4     4     4  
NOT COMPLETED     0     1     0     0     0     0  
Withdrawal by Subject                 0                 1                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PPV 5-30 Minutes After Injection Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
PPV 31-60 Minutes After Injection Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
PPV 2-4 Hours After Injection Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
PPV 24 Hours (+2 Hours) After Injection Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
PPV 7 Days (+1 Day) After Injection Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
PPV Without Injection Control Arm, no ocriplasmin intravitreal injection
Total Total of all reporting groups

Baseline Measures
    PPV 5-30 Minutes After Injection     PPV 31-60 Minutes After Injection     PPV 2-4 Hours After Injection     PPV 24 Hours (+2 Hours) After Injection     PPV 7 Days (+1 Day) After Injection     PPV Without Injection     Total  
Number of Participants  
[units: participants]
  9     9     8     4     4     4     38  
Age  
[units: years]
Mean ± Standard Deviation
  71.3  ± 8.56     65.6  ± 13.50     63.8  ± 9.38     62.5  ± 8.66     59.3  ± 11.87     69.8  ± 7.80     66.0  ± 10.5  
Gender  
[units: participants]
             
Female     7     6     6     3     1     3     26  
Male     2     3     2     1     3     1     12  



  Outcome Measures
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1.  Primary:   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 ]

2.  Other Pre-specified:   Time Necessary to Remove the Vitreous From the Eye   [ Time Frame: From first start of vitrectomy cutter till the end of core vitrectomy phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Aniz Girach
Organization: ThromboGenics
phone: +32 16751310
e-mail: aniz.girach@thrombogenics.com


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