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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168298
First received: September 12, 2005
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
Results First Received: July 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Macular Edema
Retinal Vein Occlusion
Interventions: Drug: Dexamethasone
Other: Sham injection

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
700 mg Dexamethasone No text entered.
350 mg Dexamethasone No text entered.
Sham Injection No text entered.
Total Total of all reporting groups

Baseline Measures
    700 mg Dexamethasone     350 mg Dexamethasone     Sham Injection     Total  
Number of Participants  
[units: participants]
 		  226     218     224     668  
Age, Customized  
[units: participants]
 		       
<45     14     15     13     42  
45-65     109     108     111     328  
>65     103     95     100     298  
Gender  
[units: participants]
 		       
Female     115     102     101     318  
Male     111     116     123     350  



  Outcome Measures

1.  Primary:   Best Correctd Visual Acuity (BCVA)   [ Time Frame: Day 0 - Day 180 ]
  Show Outcome Measure 1

2.  Secondary:   Visual Acuity   [ Time Frame: Months 1- 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Contrast Sensitivity   [ Time Frame: Months 1- 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Macular Thickness (OCT)   [ Time Frame: Months 1- 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Vessel Leakage (FA)   [ Time Frame: Months 1- 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Quality of Life Questionnaires   [ Time Frame: Months 1- 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714)246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00168298     History of Changes
Other Study ID Numbers: 206207-009
Study First Received: September 12, 2005
Results First Received: July 15, 2009
Last Updated: July 15, 2009
Health Authority: United States: Food and Drug Administration