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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
  Show All Outcome Measures

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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Time Frame Adverse events were collected from the injection day (Day 0) up to discontinuation from the study or completion of the study (Month 24).
Additional Description The Safety Set consisted of all subjects who received study treatment and was used for all safety analyses. All subjects were included in the Safety Set: 146 subjects in the ocriplasmin group and 74 subjects in the sham group.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Ocriplasmin   Sham
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   132/146 (90.41%)   57/74 (77.03%) 
Eye disorders     
Vitreous floaters * 1     
# participants affected / at risk   57/146 (39.04%)   6/74 (8.11%) 
# events   75   6 
Photopsia * 1     
# participants affected / at risk   44/146 (30.14%)   6/74 (8.11%) 
# events   53   7 
Vision blurred * 1     
# participants affected / at risk   28/146 (19.18%)   4/74 (5.41%) 
# events   34   6 
Cataract nuclear * 1     
# participants affected / at risk   23/146 (15.75%)   10/74 (13.51%) 
# events   30   11 
Cataract * 1     
# participants affected / at risk   22/146 (15.07%)   10/74 (13.51%) 
# events   26   10 
Macular fibrosis * 1     
# participants affected / at risk   22/146 (15.07%)   8/74 (10.81%) 
# events   26   8 
Visual acuity reduced * 1     
# participants affected / at risk   22/146 (15.07%)   18/74 (24.32%) 
# events   25   26 
Visual impairment * 1     
# participants affected / at risk   21/146 (14.38%)   4/74 (5.41%) 
# events   38   6 
Eye pain * 1     
# participants affected / at risk   20/146 (13.70%)   6/74 (8.11%) 
# events   22   10 
Photophobia * 1     
# participants affected / at risk   19/146 (13.01%)   0/74 (0.00%) 
# events   22   0 
Posterior capsule opacification * 1     
# participants affected / at risk   17/146 (11.64%)   3/74 (4.05%) 
# events   20   4 
Subretinal fluid * 1     
# participants affected / at risk   17/146 (11.64%)   4/74 (5.41%) 
# events   18   4 
Chromatopsia * 1     
# participants affected / at risk   16/146 (10.96%)   2/74 (2.70%) 
# events   18   3 
Conjunctival hemorrhage * 1     
# participants affected / at risk   15/146 (10.27%)   2/74 (2.70%) 
# events   17   2 
Metamorphopsia * 1     
# participants affected / at risk   14/146 (9.59%)   5/74 (6.76%) 
# events   15   6 
Retinal hemorrhage * 1     
# participants affected / at risk   12/146 (8.22%)   4/74 (5.41%) 
# events   12   7 
Retinal pigment epitheliopathy * 1     
# participants affected / at risk   11/146 (7.53%)   3/74 (4.05%) 
# events   12   3 
Macular hole * 1     
# participants affected / at risk   9/146 (6.16%)   1/74 (1.35%) 
# events   9   1 
Ocular discomfort * 1     
# participants affected / at risk   9/146 (6.16%)   2/74 (2.70%) 
# events   10   2 
Cystoid macular edema * 1     
# participants affected / at risk   8/146 (5.48%)   2/74 (2.70%) 
# events   10   2 
Lacrimation increased * 1     
# participants affected / at risk   8/146 (5.48%)   2/74 (2.70%) 
# events   10   3 
Foreign body sensation in eyes * 1     
# participants affected / at risk   5/146 (3.42%)   6/74 (8.11%) 
# events   5   6 
Retinal tear * 1     
# participants affected / at risk   2/146 (1.37%)   4/74 (5.41%) 
# events   2   5 
Cataract cortical * 1     
# participants affected / at risk   1/146 (0.68%)   4/74 (5.41%) 
# events   1   4 
Gastrointestinal disorders     
Nausea * 1     
# participants affected / at risk   5/146 (3.42%)   6/74 (8.11%) 
# events   6   6 
Infections and infestations     
Sinusitis * 1     
# participants affected / at risk   8/146 (5.48%)   2/74 (2.70%) 
# events   10   2 
Investigations     
Color vision tests abnormal * 1     
# participants affected / at risk   43/146 (29.45%)   14/74 (18.92%) 
# events   89   18 
Ophthalmological examination abnormal * 1     
# participants affected / at risk   29/146 (19.86%)   15/74 (20.27%) 
# events   44   21 
Intraocular pressure increased * 1     
# participants affected / at risk   10/146 (6.85%)   9/74 (12.16%) 
# events   10   11 
Visual acuity tests abnormal * 1     
# participants affected / at risk   9/146 (6.16%)   2/74 (2.70%) 
# events   10   2 
Nervous system disorders     
Headache * 1     
# participants affected / at risk   9/146 (6.16%)   4/74 (5.41%) 
# events   10   4 
Vascular disorders     
Hypertension * 1     
# participants affected / at risk   10/146 (6.85%)   1/74 (1.35%) 
# events   12   1 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA version 17.1



  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