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 (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00168298
First received: September 12, 2005
Last updated: July 15, 2013
Last verified: July 2013
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: 700 µg Dexamethasone
Drug: 350 µg Dexamethasone
Other: Sham Injection

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.

Reporting Groups
  Description
700 µg Dexamethasone 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
350 µg Dexamethasone Followed by 700 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Sham Injection Followed by 700 µg Dexamethasone Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

Participant Flow for 2 periods

Period 1:   Double-Blind Period
    700 µg Dexamethasone     350 µg Dexamethasone Followed by 700 µg Dexamethasone     Sham Injection Followed by 700 µg Dexamethasone  
STARTED     226     218     224  
COMPLETED     214     206     209  
NOT COMPLETED     12     12     15  

Period 2:   Open-Label Period
    700 µg Dexamethasone     350 µg Dexamethasone Followed by 700 µg Dexamethasone     Sham Injection Followed by 700 µg Dexamethasone  
STARTED     179 [1]   173 [1]   168 [1]
COMPLETED     172     168     160  
NOT COMPLETED     7     5     8  
[1] Not all patients who completed the double-blind period entered the open-label period.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
700 µg Dexamethasone 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
350 µg Dexamethasone Followed by 700 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Sham Injection Followed by 700 µg Dexamethasone Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Total Total of all reporting groups

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



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye   [ Time Frame: Day 180 ]

2.  Secondary:   Change From Baseline in Retinal Thickness in the Study Eye   [ Time Frame: Baseline, Day 90, Day 180 ]

3.  Secondary:   Percentage of Patients With a Change From Baseline in BCVA by Category   [ Time Frame: Baseline, Day 90 ]

4.  Secondary:   Percentage of Patients With a Change From Baseline in BCVA by Category   [ Time Frame: Baseline, Day 180 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714)246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
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, 2013
Health Authority: United States: Food and Drug Administration