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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
History of Changes
Results First Received: October 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
No text entered.

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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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