Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Primary Purpose
Age-Related Maculopathy, Choroidal Neovascularization
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Verteporfin
Verteporfin
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Maculopathy focused on measuring Ranibizumab, Lucentis, Verteporfin, Visudyne, Photodynamic therapy
Eligibility Criteria
Inclusion Criteria:
- Male or Female Patients > 50 years of age.
- Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
- Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
- If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
- Patients must be able and willing to provide written informed consent.
Exclusion Criteria:
- Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
- Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
- Choroidal neovascular membrane greater than 9 disc diameters in size.
- Previous posterior vitrectomy in the study eye.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
- Pregnant women or premenopausal women not using adequate contraception.
- History of allergy to fluorescein, Visudyne, Lucentis.
- Inability to comply with study or follow up procedures.
Sites / Locations
- Eagle Mountain Vision
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Standard Fluence Photodynamic Therapy combined with ranibizumab
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab monotherapy
Outcomes
Primary Outcome Measures
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
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.
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
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.
Secondary Outcome Measures
Time to First Retreatment After Loading Doses
Average Number of PDT Retreatments Over 12 Months
Central Macular Thickness Reduction on OCT
Average Number of Ranibizumab Retreatments Over 12 Months
Full Information
NCT ID
NCT00473642
First Posted
May 14, 2007
Last Updated
November 4, 2020
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00473642
Brief Title
Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Official Title
A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Maculopathy, Choroidal Neovascularization
Keywords
Ranibizumab, Lucentis, Verteporfin, Visudyne, Photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Standard Fluence Photodynamic Therapy combined with ranibizumab
Arm Title
2
Arm Type
Experimental
Arm Description
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Arm Title
3
Arm Type
Active Comparator
Arm Description
Ranibizumab monotherapy
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Other Intervention Name(s)
Visudyne
Intervention Description
Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Other Intervention Name(s)
Visudyne
Intervention Description
Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
Primary Outcome Measure Information:
Title
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
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
Title
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
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
Secondary Outcome Measure Information:
Title
Time to First Retreatment After Loading Doses
Time Frame
12 months
Title
Average Number of PDT Retreatments Over 12 Months
Time Frame
12 months
Title
Central Macular Thickness Reduction on OCT
Time Frame
12 months
Title
Average Number of Ranibizumab Retreatments Over 12 Months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female Patients > 50 years of age.
Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
Patients must be able and willing to provide written informed consent.
Exclusion Criteria:
Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
Choroidal neovascular membrane greater than 9 disc diameters in size.
Previous posterior vitrectomy in the study eye.
Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
Pregnant women or premenopausal women not using adequate contraception.
History of allergy to fluorescein, Visudyne, Lucentis.
Inability to comply with study or follow up procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott J Westhouse, DO
Organizational Affiliation
Oklahoma State University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond Townsend, MD
Organizational Affiliation
Oklahoma State University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Saurino, DO
Organizational Affiliation
Oklahoma State University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eagle Mountain Vision
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
12. IPD Sharing Statement
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Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
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