Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

Completed · Phase 2

Conditions studied: Choroidal Neovascularization, Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00492284

Run by

QLT Inc.

People needed

162

Starts

2007-07-01

Expected to finish

2010-05-01

Last updated by the study team

2011-06-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Retina Centers, PC — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Campbell, California, United States
• Study site — Los Angeles, California, United States
• Study site — Poway, California, United States
• Study site — Sacramento, California, United States
• Study site — Torrance, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Davenport, Iowa, United States
• Study site — Missoula, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Portsmouth, New Hampshire, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — West Mifflin, Pennsylvania, United States
• Study site — Arlington, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — London, Ontario, Canada

Full record on ClinicalTrials.gov

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