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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781859
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : January 28, 2013
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Vitreomacular Adhesion
Interventions: Drug: 125 µg Ocriplasmin
Drug: Placebo

  Participant Flow

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
No text entered.

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

Participant Flow:   Overall Study
    Ocriplasmin 125µg   Placebo
STARTED   219   107 
COMPLETED   200   98 
Adverse Event                2                2 
Withdrawal by Subject                8                4 
Lost to Follow-up                6                3 
Death                3                0 

  Baseline Characteristics

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
Ocriplasmin 125µg 125µg microplasmin intravitreal injection
Placebo Intravitreal injection of placebo
Total Total of all reporting groups

Baseline Measures
   Ocriplasmin 125µg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 219   107   326 
[Units: Years]
Mean (Standard Deviation)
 71.5  (10.25)   71.1  (10.04)   71.3  (10.17) 
[Units: Participants]
Female   148   59   207 
Male   71   48   119 

  Outcome Measures

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

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
No text entered.

  More Information

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: Petra Kozma-Wiebe
Organization: ThromboGenics
phone: +32 16751310

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: ThromboGenics Identifier: NCT00781859     History of Changes
Other Study ID Numbers: TG-MV-006
First Submitted: October 28, 2008
First Posted: October 29, 2008
Results First Submitted: December 20, 2012
Results First Posted: January 28, 2013
Last Update Posted: December 17, 2014