Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01429441
First received: September 2, 2011
Last updated: February 18, 2016
Last verified: January 2016
Results First Received: October 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vitreomacular Adhesion Including Macular Hole
Interventions: Drug: Ocriplasmin
Other: Sham injection

  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
This study was conducted at 25 study sites in the United States. The first subject was enrolled on 02 November 2011 and the last subject completed the study on 22 October 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ocriplasmin Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Sham Subjects in the sham group received a single sham injection

Participant Flow:   Overall Study
    Ocriplasmin     Sham  
STARTED     146     74  
COMPLETED     108     51  
NOT COMPLETED     38     23  
Adverse Event                 5                 1  
Death                 0                 2  
Lost to Follow-up                 5                 2  
Physician Decision                 1                 0  
Withdrawal by Subject                 27                 18  



  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.
Safety Set: The Safety Set consists of all subjects who received treatment.

Reporting Groups
  Description
Ocriplasmin Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Sham Subjects in the sham group received a single sham injection
Total Total of all reporting groups

Baseline Measures
    Ocriplasmin     Sham     Total  
Number of Participants  
[units: participants]
  146     74     220  
Age  
[units: years]
Mean (Standard Deviation)
  69.4  (9.99)     68.5  (10.94)     69.1  (10.30)  
Gender  
[units: participants]
     
Female     103     45     148  
Male     43     29     72  



  Outcome Measures
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1.  Primary:   Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28   [ Time Frame: Day 28 ]

2.  Secondary:   Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24   [ Time Frame: Month 24 ]


  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
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  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.


Results Point of Contact:  
Name/Title: Dr. Petra Kozma-Wiebe
Organization: ThromboGenics N.V.
phone: +32 16 751 497
e-mail: petra.kozma@thrombogenics.com



Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01429441     History of Changes
Other Study ID Numbers: TG-MV-014
Study First Received: September 2, 2011
Results First Received: October 29, 2015
Last Updated: February 18, 2016
Health Authority: United States: Food and Drug Administration