Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01566526
First received: March 27, 2012
Last updated: March 27, 2013
Last verified: March 2013
Results First Received: March 27, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Retinal Vein Occlusion
Macular Oedema
Intervention: Drug: dexamethasone intravitreal implant 0.7 mg

  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
Patients Previously Treated With OZURDEX® OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Participant Flow:   Overall Study
    Patients Previously Treated With OZURDEX®  
STARTED     26  
COMPLETED     26  
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
Patients Previously Treated With OZURDEX® OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Baseline Measures
    Patients Previously Treated With OZURDEX®  
Number of Participants  
[units: participants]
  26  
Age, Customized  
[units: Participants]
 
41 to 50 years     3  
51 to 60 years     10  
61 to 70 years     4  
71 to 80 years     8  
81 to 90 years     1  
Gender  
[units: Participants]
 
Female     14  
Male     12  



  Outcome Measures
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1.  Primary:   Time to OZURDEX® Re-Injection in the Study Eye   [ Time Frame: Up to 12 Months ]

2.  Secondary:   Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye   [ Time Frame: Baseline, 7 to 12 weeks following the last injection ]

3.  Secondary:   Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye   [ Time Frame: Baseline, Up to 12 Months ]

4.  Secondary:   Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye   [ Time Frame: Baseline, Up to 12 Months ]

5.  Secondary:   Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection   [ Time Frame: Baseline, 7 to 12 weeks following the last injection ]

6.  Secondary:   Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye   [ Time Frame: Baseline, Up to 12 Months ]

7.  Secondary:   Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye   [ Time Frame: Baseline, Up to 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
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Results Point of Contact:  
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01566526     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/012
Study First Received: March 27, 2012
Results First Received: March 27, 2013
Last Updated: March 27, 2013
Health Authority: Belgium: Institutional Review Board