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Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (EXCITE)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00275821
First received: January 11, 2006
Last updated: February 22, 2011
Last verified: February 2011
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Age Related Macular Degeneration
Interventions: Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Drug: Ranibizumab 0.3 mg monthly

  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
No text entered.

Reporting Groups
  Description
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.3 mg Monthly Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Participant Flow:   Overall Study
    Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly     Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly     Ranibizumab 0.3 mg Monthly  
STARTED     120     118     115  
COMPLETED     106     95     103  
NOT COMPLETED     14     23     12  
Adverse Event                 4                 12                 5  
Administrative problems                 3                 4                 4  
Withdrawal by Subject                 0                 2                 1  
Lost to Follow-up                 0                 1                 1  
Death                 0                 2                 1  
Lack of Efficacy                 2                 1                 0  
Protocol Violation                 5                 1                 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.
No text entered.

Reporting Groups
  Description
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.3 mg Monthly Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly     Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly     Ranibizumab 0.3 mg Monthly     Total  
Number of Participants  
[units: participants]
  120     118     115     353  
Age, Customized  
[units: Participants]
       
50 - < 65     13     12     10     35  
65 - < 75     37     28     45     110  
75 - < 85     61     72     46     179  
≥ 85     9     6     14     29  
Gender  
[units: participants]
       
Female     70     73     66     209  
Male     50     45     49     144  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12   [ Time Frame: Baseline to Month 12 ]

2.  Secondary:   Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12   [ Time Frame: Baseline to Month 12 ]

3.  Secondary:   Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12   [ Time Frame: Baseline to Month 12 ]

4.  Secondary:   Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12   [ Time Frame: Baseline to Month 12 ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00275821     History of Changes
Other Study ID Numbers: CRFB002A2302
Study First Received: January 11, 2006
Results First Received: December 20, 2010
Last Updated: February 22, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP