Ranibizumab and Reduced Fluence PDT for AMD (RAP)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Texas Retina Associates
ClinicalTrials.gov Identifier:
NCT00527475
First received: September 9, 2007
Last updated: June 5, 2013
Last verified: June 2013
Results First Received: April 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Macular Degeneration
Interventions: Drug: ranibizumab
Drug: verteporfin

  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
Ranibizumab Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
Reduced Fluence PDT & Ranibizumab Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.

Participant Flow:   Overall Study
    Ranibizumab     Reduced Fluence PDT & Ranibizumab  
STARTED     30     30  
COMPLETED     27     29  
NOT COMPLETED     3     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.
No text entered.

Reporting Groups
  Description
Group I Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
Group II Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Total Total of all reporting groups

Baseline Measures
    Group I     Group II     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age [1]
[units: years]
Mean ± Standard Deviation
  79.1  ± 8.35     79.3  ± 7.23     79.2  ± 7.72  
Gender  
[units: participants]
     
Female     14     18     32  
Male     16     12     28  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
[1] Average age



  Outcome Measures

1.  Primary:   The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.   [ Time Frame: 1 year ]

2.  Secondary:   The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 NOT 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.


Results Point of Contact:  
Name/Title: David Callanan, MD
Organization: Texas Retina Associates
phone: 817-261-9625
e-mail: dcallanan@texasretina.com


No publications provided


Responsible Party: Texas Retina Associates
ClinicalTrials.gov Identifier: NCT00527475     History of Changes
Other Study ID Numbers: RAP AMD Trial
Study First Received: September 9, 2007
Results First Received: April 19, 2013
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration