Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00775411
First received: October 16, 2008
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: August 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Choroidal Neovascularization
Age-Related Maculopathy
Interventions: Drug: dexamethasone
Biological: ranibizumab

  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
No text entered.

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
700 µg Dexamethasone + Ranibizumab 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.

Participant Flow:   Overall Study
    700 µg Dexamethasone + Ranibizumab  
STARTED     44  
COMPLETED     43  
NOT COMPLETED     1  



  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
700 µg Dexamethasone + Ranibizumab 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.

Baseline Measures
    700 µg Dexamethasone + Ranibizumab  
Number of Participants  
[units: participants]
  44  
Age  
[units: Years]
Mean ± Standard Deviation
  72.3  ± 10.43  
Gender  
[units: Participants]
 
Female     25  
Male     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4   [ Time Frame: Baseline, Week 4 ]

2.  Secondary:   Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26   [ Time Frame: Baseline, Week 26 ]


  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
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: Allergan
ClinicalTrials.gov Identifier: NCT00775411     History of Changes
Other Study ID Numbers: 206207-019
Study First Received: October 16, 2008
Results First Received: August 1, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration