Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Information source: QLT Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choroidal Neovascularization; Macular Degeneration
Intervention: verteporfin, ranibizumab (Drug); verteporfin, ranibizumab, dexamethasone (Drug); ranibizumab (Drug); verteporfin, ranibizumab, dexamethasone (Drug)
Phase: Phase 2
Status: Active, not recruiting
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 CNV Secondary to AMD.
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable are mean number of retreatments (Day 0 excluded) and mean change from baseline in best-corrected VA score.
Secondary outcome: gain = or > 15 letters;
VA change = or > 0-letter gain;
loss = or > 15 letters;
Frequency distribution of VA change;
Central retinal thickness--mean and mean change;
Lesion size(GLD)--mean and mean change;
adverse events, FA assessment
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Treatment naive for choroidal neovascularization (CNV) secondary to 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 (approx = or <9disc areas [DA])
- Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA score of 25 - 73 letters (approx 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
Retina Centers, PC, Tucson, Arizona 85704-5614, United States
Phoenix, Arizona, United States
Vancouver, British Columbia, Canada
Beverly Hills, California, United States
Poway, California, United States
Campbell, California, United States
Sacramento, California, United States
Torrance, California, United States
Los Angeles, 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
Toronto, Ontario, Canada
London, Ontario, Canada
Portland, Oregon, United States
West Mifflin, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Temple, Texas, United States
Arlington, Texas, United States
Seattle, Washington, United States
Additional Information
Starting date: July 2007
Ending date: May 2010
Last updated: May 30, 2008
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