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Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00473642
Recruitment Status : Completed
First Posted : May 15, 2007
Results First Posted : November 8, 2012
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Age-Related Maculopathy
Choroidal Neovascularization
Interventions Drug: Ranibizumab
Drug: Verteporfin
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Fluence PDT 50% Fluence PDT Ranibizumab
Hide Arm/Group Description Standard Fluence Photodynamic Therapy combined with ranibizumab Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab Ranibizumab monotherapy
Period Title: Overall Study
Started 10 11 10
Completed 8 10 8
Not Completed 2 1 2
Arm/Group Title Standard Fluence PDT 50% Fluence PDT Ranibizumab Total
Hide Arm/Group Description Standard Fluence Photodynamic Therapy combined with ranibizumab Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab Ranibizumab monotherapy Total of all reporting groups
Overall Number of Baseline Participants 10 11 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
2
  18.2%
1
  10.0%
4
  12.9%
>=65 years
9
  90.0%
9
  81.8%
9
  90.0%
27
  87.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 10 participants 31 participants
76.9  (3.1) 73.4  (2.1) 76.3  (2.8) 74  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 31 participants
Female
8
  80.0%
7
  63.6%
8
  80.0%
23
  74.2%
Male
2
  20.0%
4
  36.4%
2
  20.0%
8
  25.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 10 participants 31 participants
10 11 10 31
1.Primary Outcome
Title Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
Hide Description Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT Reduced Fluence PDT Ranibizumab Monotherapy
Hide Arm/Group Description:

Standard Fluence Photodynamic Therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Ranibizumab monotherapy

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Overall Number of Participants Analyzed 10 11 10
Mean (95% Confidence Interval)
Unit of Measure: Letters
5.9
(-0.4 to 12.2)
7.6
(3.6 to 11.6)
16.4
(12.4 to 20.4)
2.Primary Outcome
Title Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
Hide Description Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT 50% Fluence PDT Ranibizumab
Hide Arm/Group Description:
Standard Fluence Photodynamic Therapy combined with ranibizumab
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab monotherapy
Overall Number of Participants Analyzed 10 11 10
Mean (Standard Deviation)
Unit of Measure: letters
5.9  (6.3) 7.6  (4) 16.4  (4)
3.Secondary Outcome
Title Time to First Retreatment After Loading Doses
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT Reduced Fluence PDT Ranibizumab Monotherapy
Hide Arm/Group Description:

Standard Fluence Photodynamic Therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Ranibizumab monotherapy

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Overall Number of Participants Analyzed 10 11 10
Mean (Standard Deviation)
Unit of Measure: Month
2.86  (0.38) 2.90  (0.71) 2.86  (0.63)
4.Secondary Outcome
Title Average Number of PDT Retreatments Over 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT Reduced Fluence PDT
Hide Arm/Group Description:

Standard Fluence Photodynamic Therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Number of Treatments
0.67  (0.24) 0.55  (0.22)
5.Secondary Outcome
Title Central Macular Thickness Reduction on OCT
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT Reduced Fluence PDT Ranibizumab Monotherapy
Hide Arm/Group Description:

Standard Fluence Photodynamic Therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Ranibizumab monotherapy

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Overall Number of Participants Analyzed 10 11 10
Mean (Standard Deviation)
Unit of Measure: micron (um)
42.9  (20.1) 76.1  (37.8) 34.9  (10.9)
6.Secondary Outcome
Title Average Number of Ranibizumab Retreatments Over 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluence PDT Reduced Fluence PDT Ranibizumab Monotherapy
Hide Arm/Group Description:

Standard Fluence Photodynamic Therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Ranibizumab monotherapy

Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Overall Number of Participants Analyzed 10 11 10
Mean (Standard Deviation)
Unit of Measure: Number of Treatments
2.67  (0.53) 2.91  (0.62) 4.14  (0.72)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Fluence PDT 50% Fluence PDT Ranibizumab
Hide Arm/Group Description Standard Fluence Photodynamic Therapy combined with ranibizumab Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab Ranibizumab monotherapy
All-Cause Mortality
Standard Fluence PDT 50% Fluence PDT Ranibizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Standard Fluence PDT 50% Fluence PDT Ranibizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)      2/10 (20.00%)    
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION * [1]  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
cardiopulmonary arrest * [2]  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
greater than 2 months after last ranibizumab
[2]
following hip fracture and complications greater than 2 months after ranibizumab
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Standard Fluence PDT 50% Fluence PDT Ranibizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)      0/10 (0.00%)    
This study was limited by a small number of subjects. Additionally, several subjects did not meet the 12 month study endpoint. These subjects were included in the final analysis if their last visit was within 2 months of the final endpoint.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Scott Westhouse, DO
Organization: Retina Specialists of Michigan
Phone: 616-954-2020
EMail: s.westhouse@gmail.com
Layout table for additonal information
Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00473642    
Other Study ID Numbers: 2007002
First Submitted: May 14, 2007
First Posted: May 15, 2007
Results First Submitted: September 20, 2011
Results First Posted: November 8, 2012
Last Update Posted: November 6, 2020