A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00412958
First received: December 18, 2006
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: Vitrectomy
Interventions: Drug: Ocriplasmin 25µg
Drug: Ocriplasmin 75µg
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
The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ocriplasmin 25µg 25µg ocriplasmin intravitreal injection.
Ocriplasmin 75µg 75µg ocriplasmin intravitreal injection.
Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection.
Placebo Intravitreal injection of placebo.

Participant Flow:   Overall Study
    Ocriplasmin 25µg     Ocriplasmin 75µg     Ocriplasmin 125µg     Placebo  
STARTED     29     33     32     31  
COMPLETED     26     29     32     30  
NOT COMPLETED     3     4     0     1  
Withdrawal by Subject                 3                 0                 0                 1  
Adverse Event                 0                 1                 0                 0  
Lost to Follow-up                 0                 1                 0                 0  
Death                 0                 1                 0                 0  
Transport issue                 0                 1                 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
Ocriplasmin 25µg 25µg ocriplasmin intravitreal injection
Ocriplasmin 75µg 75µg ocriplasmin intravitreal injection.
Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection.
Placebo Intravitreal injection of placebo.
Total Total of all reporting groups

Baseline Measures
    Ocriplasmin 25µg     Ocriplasmin 75µg     Ocriplasmin 125µg     Placebo     Total  
Number of Participants  
[units: participants]
  29     33     32     31     125  
Age  
[units: years]
Mean ± Standard Deviation
  66.9  ± 8.28     68.8  ± 9.07     66.9  ± 11.40     65.7  ± 11.60     66.1  ± 10.16  
Gender  
[units: participants]
         
Female     20     23     20     22     85  
Male     9     10     12     9     40  



  Outcome Measures

1.  Primary:   Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect   [ Time Frame: Day 7 ]


  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 less than or equal to 60 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


Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00412958     History of Changes
Other Study ID Numbers: TG-MV-003
Study First Received: December 18, 2006
Results First Received: December 20, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration