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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.


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


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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