Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
NCT ID: NCT00492284
Last Updated: 2011-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2007-07-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1/4 Fluence Triple Therapy
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
verteporfin
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
ranibizumab
0.5 mg intravitreal injection
dexamethasone
0.5 mg intravitreal injection
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
verteporfin
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
ranibizumab
0.5 mg intravitreal injection
dexamethasone
0.5 mg intravitreal injection
1/2 Fluence Double Therapy
Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
verteporfin
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
ranibizumab
0.5 mg intravitreal injection
Ranibizumab
Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
ranibizumab
0.5 mg intravitreal injection
Interventions
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verteporfin
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
verteporfin
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
ranibizumab
0.5 mg intravitreal injection
dexamethasone
0.5 mg intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subfoveal CNV due to AMD
* CNV must be = or \>50 % of the entire lesion
* All lesion composition types with a lesion greatest linear dimension (GLD) \< 5400 microns (approximately = or \<9 disc areas \[DA\])
* Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive
Exclusion Criteria
* Intraocular surgery within 3 months of enrollment
* Inability to attend the protocol-required visits
* Known allergies or hypersensitivity to any of the study treatments.
* Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk
* Uncontrolled glaucoma, defined as (1)subject is on \>1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
* If subject has had a stroke within the last year
50 Years
ALL
No
Sponsors
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QLT Inc.
INDUSTRY
Responsible Party
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QLT Inc.
Principal Investigators
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Henry Hudson, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Centers, PC
Allen Ho, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Diagnostic & Treatment Associates, LLC
Andrew Strong, Ph.D
Role: STUDY_CHAIR
QLT Inc.
Oscar Cuzzani, MD
Role: STUDY_DIRECTOR
QLT Inc.
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Retina Centers, PC
Tucson, Arizona, United States
Beverly Hills, California, United States
Campbell, California, United States
Los Angeles, California, United States
Poway, California, United States
Sacramento, California, United States
Torrance, California, United States
Fort Myers, Florida, United States
Indianapolis, Indiana, United States
Davenport, Iowa, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Portsmouth, New Hampshire, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Arlington, Texas, United States
Temple, Texas, United States
Seattle, Washington, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Countries
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Other Identifiers
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BPD OCR 022
Identifier Type: -
Identifier Source: org_study_id
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