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Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00517010
First received: August 15, 2007
Last updated: June 28, 2016
Last verified: June 2016
Results First Received: December 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Age-related Macular Degeneration
Intervention: Drug: Proton beam irradiation and 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
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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
Lucentis Combined With Proton Beam Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.

Participant Flow:   Overall Study
    Lucentis Combined With Proton Beam  
STARTED     6  
COMPLETED     5  
NOT COMPLETED     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.
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Reporting Groups
  Description
Lucentis Combined With Proton Beam Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.

Baseline Measures
    Lucentis Combined With Proton Beam  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     6  
Gender  
[units: participants]
 
Female     2  
Male     4  
Best corrected visual acuity [1]
[units: logMAR best corrected visual acuity]
Mean (Standard Deviation)
  0.58  (0.26)  
Optical coherence tomography central macular thickness [2]
[units: microns]
Mean (Standard Deviation)
  335  (67)  
[1] Number of letters read correctly
[2] Central macular thickness for quantitative measure; qualitative measure of presence or absence of intraretinal or subretinal fluid



  Outcome Measures
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1.  Primary:   Incidence and Severity of Ocular Adverse Events   [ Time Frame: 24 months ]

2.  Secondary:   1. Change in BCVA From Baseline   [ Time Frame: 24 months ]


  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: Susanna Park MD PhD
Organization: University of California Davis
phone: 916-734-6074
e-mail: sscpark@ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00517010     History of Changes
Other Study ID Numbers: 200715285
100,481 ( Other Identifier: FDA IND )
Study First Received: August 15, 2007
Results First Received: December 2, 2015
Last Updated: June 28, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board