A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01571557
First received: April 3, 2012
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: June 22, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Macular Edema
Retinal Vein Occlusion
Intervention: Drug: dexamethasone 700 ug intravitreal implant

  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
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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
OZURDEX® OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.

Participant Flow:   Overall Study
    OZURDEX®  
STARTED     573  
COMPLETED     573  
NOT COMPLETED     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.
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Reporting Groups
  Description
OZURDEX® OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.

Baseline Measures
    OZURDEX®  
Number of Participants  
[units: participants]
  573  
Age, Customized  
[units: Participants]
 
31 to 40 years     4  
41 to 50 years     13  
51 to 60 years     69  
61 to 70 years     127  
71 to 80 years     235  
81 to 90 years     119  
91 to 100 years     6  
Gender  
[units: Participants]
 
Female     286  
Male     287  



  Outcome Measures
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1.  Primary:   Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye   [ Time Frame: Baseline, 48 Weeks ]

3.  Secondary:   Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye   [ Time Frame: Baseline, 48 Weeks ]

4.  Secondary:   Mean Change From Baseline in Central Retinal Thickness   [ Time Frame: Baseline, Week 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: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01571557     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/011
Study First Received: April 3, 2012
Results First Received: June 22, 2015
Last Updated: June 22, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices