Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00798317
First received: November 25, 2008
Last updated: January 30, 2013
Last verified: January 2013
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: Ocriplasmin 125µg
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 23 Dec 2008 and last patient completed the study on 15 Jun 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     245     81  
COMPLETED     235     74  
NOT COMPLETED     10     7  
Physician Decision                 0                 1  
Withdrawal by Subject                 5                 4  
Lost to Follow-up                 2                 2  
Adverse Event                 2                 0  
Death                 1                 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 ocriplasmin intravitreal injection.
Placebo Intravitreal injection of placebo
Total Total of all reporting groups

Baseline Measures
    Ocriplasmin 125µg     Placebo     Total  
Number of Participants  
[units: participants]
  245     81     326  
Age  
[units: years]
Mean ± Standard Deviation
  72.6  ± 7.56     70.2  ± 10.85     72.0  ± 8.54  
Gender  
[units: participants]
     
Female     166     56     222  
Male     79     25     104  



  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


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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  


Results Point of Contact:  
Name/Title: Aniz Girach
Organization: ThromboGenics
phone: +3216751 447
e-mail: aniz.girach@thrombogenics.com


No publications provided by ThromboGenics

Publications automatically indexed to this study:

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00798317     History of Changes
Other Study ID Numbers: TG-MV-007
Study First Received: November 25, 2008
Results First Received: December 20, 2012
Last Updated: January 30, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration