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Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT00539734
First received: October 2, 2007
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
Results First Received: February 8, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Age-related Macular Degeneration
Intervention: Drug: 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
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Reporting Groups
  Description
Ranibizumab Group Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.

Participant Flow:   Overall Study
    Ranibizumab Group  
STARTED     26  
COMPLETED     25  
NOT COMPLETED     1  
Protocol Violation                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Ranibizumab Group Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.

Baseline Measures
    Ranibizumab Group  
Number of Participants  
[units: participants]
 		  26  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     15  
Age  
[units: years]
Mean ± Standard Deviation 		  66.5  ± 9.22  
Gender  
[units: participants]
 		 
Female     16  
Male     10  
Region of Enrollment  
[units: participants]
 		 
Thailand     26  



  Outcome Measures
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1.  Primary:   Height (Amplitude) of Multifocal ERG Signal   [ Time Frame: baseline, 3 months ]
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2.  Primary:   Time to Response (Implicit Time) of Multifocal ERG Signal   [ Time Frame: baseline, 3 months ]
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3.  Secondary:   Postoperative Complication   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Small number of participants  


Results Point of Contact:  
Name/Title: Patama Bhurayanontachai
Organization: Prince of Songkla University
phone: 66-74-451380
e-mail: tpatama@hotmail.com


Publications:


Responsible Party: Dr.Patama Bhurayanontachai, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT00539734     History of Changes
Other Study ID Numbers: 50/362-003-2
Study First Received: October 2, 2007
Results First Received: February 8, 2011
Last Updated: April 11, 2011
Health Authority: Thailand: Ethical Committee