Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

This study has been terminated.
(Lack of efficacy)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David M. Brown, M.D., Greater Houston Retina Research
ClinicalTrials.gov Identifier:
NCT00423189
First received: January 16, 2007
Last updated: February 5, 2016
Last verified: February 2016
Results First Received: October 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Age-Related Macular Degeneration
Interventions: Drug: Ranibizumab (Lucentis)
Drug: 0.5mg 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
7 patients, over a 12 month period were followed after receiving treatment of either decreased fluence(2 different fluences) and 0.5mg ranibizumab, as compared to monotherapy of 0.5mg ranibizumab at a single site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
patients that were considered to have recalcitrant wet age related macular degeneration were recruited for this trial

Reporting Groups
  Description
Ranibizumab Only drug - intravitreal ranibizumab
Ranibizumab and 40% Fluence PDT(Procedure) 40% fluence photodynamic therapy - procedure
Ranibizumab and 20% Fluence PDT(Procedure) 20% fluence photodynamic therapy - procedure

Participant Flow:   Overall Study
    Ranibizumab Only     Ranibizumab and 40% Fluence PDT(Procedure)     Ranibizumab and 20% Fluence PDT(Procedure)  
STARTED     2     3     2  
COMPLETED     2     2     2  
NOT COMPLETED     0     1     0  
Death                 0                 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
Arm 1 drug - intravitreal ranibizumab
Arm 2 40% fluence photodynamic therapy - procedure
Arm 3 20% fluence photodynamic therapy - procedure
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Arm 3     Total  
Number of Participants  
[units: participants]
  2     3     2     7  
Age  
[units: years]
Mean (Standard Deviation)
  73  (3)     78  (7)     67  (5)     72  (5)  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     2     3     2     7  
Region of Enrollment  
[units: participants]
       
United States     2     03     2     7  



  Outcome Measures
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1.  Primary:   Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)   [ Time Frame: 1 Year ]

2.  Secondary:   Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months   [ Time Frame: 1 Year ]

3.  Secondary:   OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)   [ Time Frame: 1 Year ]

4.  Secondary:   Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months   [ Time Frame: 1 Year ]

5.  Secondary:   Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab   [ Time Frame: 1 Year ]


  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
The trial was discontinued due to a lack of efficacy.


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


Results Point of Contact:  
Name/Title: David M. Brown
Organization: Retina Consultants of Houston
phone: 713-524-3434
e-mail: dmbmd@houstonretina.com


Publications:

Responsible Party: David M. Brown, M.D., Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT00423189     History of Changes
Other Study ID Numbers: LUV
Study First Received: January 16, 2007
Results First Received: October 17, 2012
Last Updated: February 5, 2016
Health Authority: United States: Food and Drug Administration