Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Information source: QLT Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choroidal Neovascularization; Macular Degeneration
Intervention: verteporfin (Drug); verteporfin (Drug); ranibizumab (Drug); dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: QLT Inc. Official(s) and/or principal investigator(s): Henry Hudson, MD, Principal Investigator, Affiliation: Retina Centers, PC Allen Ho, MD, Principal Investigator, Affiliation: Retina Diagnostic & Treatment Associates, LLC Andrew Strong, Ph.D, Study Chair, Affiliation: QLT Inc. Oscar Cuzzani, MD, Study Director, Affiliation: QLT Inc.
Summary
The objective of this study is to determine if combination therapy (reduced-fluence Visudyne
followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne
followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment
rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an
acceptable safety profile.
Clinical Details
Official title: A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Number of Retreatments (Day 0 Excluded)Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
Secondary outcome: Mean Number of Retreatments (Day 0 Excluded)Mean Change From Baseline in Study Eye Best-Corrected VA Score Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline Mean Change From Baseline in Central Retinal Thickness Mean Change From Baseline in Lesion Size
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Treatment naive for choroidal neovascularization (CNV) secondary to age-related
macular degeneration (AMD) in the study eye except for laser treatment outside the
subfoveal area
- 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:
- Subfoveal geographic atrophy or subfoveal fibrosis of the study eye
- 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
Locations and Contacts
Mobile, Alabama, United States
Calgary, Alberta, Canada
Phoenix, Arizona, United States
Retina Centers, PC, Tucson, Arizona, United States
Vancouver, British Columbia, Canada
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
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
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
Additional Information
Starting date: July 2007
Last updated: May 31, 2011
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