Clinical trial NCT00492284: Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Macular Degeneration
Keywords: Macular Degeneration
AMD
CNV
Choroidal neovascularization
Photodynamic therapy
CNV Secondary to Age Related Macular Degeneration
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 162
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean Number of Retreatments (Day 0 Excluded)
timeFrame: Month 1 to Month 12
measure: Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Mean Number of Retreatments (Day 0 Excluded)
timeFrame: Month 1 to Month 24
measure: Mean Change From Baseline in Study Eye Best-Corrected VA Score
timeFrame: Baseline to Month 24
measure: Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
timeFrame: Baseline to Month 12, Baseline to Month 24
measure: Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
timeFrame: Baseline to Month 12, Baseline to Month 24
measure: Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
timeFrame: Baseline to Month 12, Baseline to Month 24
measure: Mean Change From Baseline in Central Retinal Thickness
timeFrame: Baseline to Month 12, Baseline to Month 24
measure: Mean Change From Baseline in Lesion Size
timeFrame: Baseline to Month 12, Baseline to Month 24
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Campbell
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Poway
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Torrance
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Portsmouth
country: United States
state: New Hampshire
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Retina Centers, PC
name: Henry Hudson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Diagnostic & Treatment Associates, LLC
name: Allen Ho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: QLT Inc.
name: Andrew Strong, Ph.D
role: STUDY_CHAIR
affiliation: QLT Inc.
name: Oscar Cuzzani, MD
role: STUDY_DIRECTOR
References: