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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00511706
First received: August 2, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: August 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Choroidal Neovascularization
Age-Related Maculopathy
Interventions: Drug: dexamethasone
Biological: ranibizumab
Other: sham

  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
Dexamethasone and Ranibizumab Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
Sham and Ranibizumab Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.

Participant Flow:   Overall Study
    Dexamethasone and Ranibizumab     Sham and Ranibizumab  
STARTED     123     120  
COMPLETED     115     115  
NOT COMPLETED     8     5  



  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
Dexamethasone and Ranibizumab Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
Sham and Ranibizumab Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
Total Total of all reporting groups

Baseline Measures
    Dexamethasone and Ranibizumab     Sham and Ranibizumab     Total  
Number of Participants  
[units: participants]
  123     120     243  
Age  
[units: Years]
Mean ± Standard Deviation
  76.1  ± 8.83     76.2  ± 8.50     76.1  ± 8.65  
Gender  
[units: Participants]
     
Female     76     69     145  
Male     47     51     98  



  Outcome Measures
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1.  Primary:   Injection Free Interval   [ Time Frame: Week 1 to Week 25 ]

2.  Secondary:   Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25   [ Time Frame: Baseline, Week 25 ]

3.  Secondary:   Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye   [ Time Frame: Baseline, Week 25 ]

4.  Secondary:   Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye   [ Time Frame: Screening (-Week 28), Week 25 ]


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


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00511706     History of Changes
Other Study ID Numbers: 206207-016
Study First Received: August 2, 2007
Results First Received: August 1, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration