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Ranibizumab and Reduced Fluence PDT for AMD (RAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527475
First Posted: September 11, 2007
Last Update Posted: June 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Texas Retina Associates
Results First Submitted: April 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 79.1  (8.35)   79.3  (7.23)   79.2  (7.72) 
[1] Average age
Gender 
[Units: Participants]
     
Female   14   18   32 
Male   16   12   28 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  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 reported.   Anticipated Reporting Date:   No text entered.  


  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



Responsible Party: Texas Retina Associates
ClinicalTrials.gov Identifier: NCT00527475     History of Changes
Other Study ID Numbers: RAP AMD Trial
First Submitted: September 9, 2007
First Posted: September 11, 2007
Results First Submitted: April 19, 2013
Results First Posted: June 7, 2013
Last Update Posted: June 7, 2013