Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00781859
First received: October 28, 2008
Last updated: April 4, 2014
Last verified: April 2014
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Vitreomacular Adhesion
Interventions: Drug: 125 µg Ocriplasmin
Drug: Placebo

  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
First patient was recruited on 30 Dec 2008 and last patient completed the study on 17 March 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection
Placebo Intravitreal injection of placebo

Participant Flow:   Overall Study
    Ocriplasmin 125µg     Placebo  
STARTED     219     107  
COMPLETED     200     98  
NOT COMPLETED     19     9  
Adverse Event                 2                 2  
Withdrawal by Subject                 8                 4  
Lost to Follow-up                 6                 3  
Death                 3                 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
Ocriplasmin 125µg 125µg microplasmin intravitreal injection
Placebo Intravitreal injection of placebo
Total Total of all reporting groups

Baseline Measures
    Ocriplasmin 125µg     Placebo     Total  
Number of Participants  
[units: participants]
  219     107     326  
Age  
[units: years]
Mean ± Standard Deviation
  71.5  ± 10.25     71.1  ± 10.04     71.3  ± 10.17  
Gender  
[units: participants]
     
Female     148     59     207  
Male     71     48     119  



  Outcome Measures
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1.  Primary:   Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.   [ Time Frame: Day 28 ]

2.  Secondary:   Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28   [ Time Frame: Day 28 ]


  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: Aniz Girach
Organization: ThromboGenics
phone: +32 16751310
e-mail: aniz.girach@thrombogenics.com


No publications provided by ThromboGenics

Publications automatically indexed to this study:

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00781859     History of Changes
Other Study ID Numbers: TG-MV-006
Study First Received: October 28, 2008
Results First Received: December 20, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration