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

Primary Purpose

Choroidal Neovascularization, Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
verteporfin
verteporfin
ranibizumab
dexamethasone
Sponsored by
QLT Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Macular Degeneration, AMD, CNV, Choroidal neovascularization, Photodynamic therapy, CNV Secondary to Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Centers, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1/4 Fluence Triple Therapy

1/2 Fluence Triple Therapy

1/2 Fluence Double Therapy

Ranibizumab

Arm Description

Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter

Outcomes

Primary Outcome Measures

Mean Number of Retreatments (Day 0 Excluded)
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

Secondary Outcome Measures

Mean Number of Retreatments (Day 0 Excluded)
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Mean Change From Baseline in Study Eye Best-Corrected VA Score
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
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
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

Full Information

First Posted
June 25, 2007
Last Updated
May 31, 2011
Sponsor
QLT Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00492284
Brief Title
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Acronym
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
QLT Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Macular Degeneration
Keywords
Macular Degeneration, AMD, CNV, Choroidal neovascularization, Photodynamic therapy, CNV Secondary to Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1/4 Fluence Triple Therapy
Arm Type
Experimental
Arm Description
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Arm Title
1/2 Fluence Triple Therapy
Arm Type
Experimental
Arm Description
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Arm Title
1/2 Fluence Double Therapy
Arm Type
Experimental
Arm Description
Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
Intervention Type
Drug
Intervention Name(s)
verteporfin
Other Intervention Name(s)
Visudyne, photodynamic therapy
Intervention Description
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
Intervention Type
Drug
Intervention Name(s)
verteporfin
Other Intervention Name(s)
Visudyne, photodynamic therapy
Intervention Description
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg intravitreal injection
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
0.5 mg intravitreal injection
Primary Outcome Measure Information:
Title
Mean Number of Retreatments (Day 0 Excluded)
Description
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Time Frame
Month 1 to Month 12
Title
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Mean Number of Retreatments (Day 0 Excluded)
Description
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Time Frame
Month 1 to Month 24
Title
Mean Change From Baseline in Study Eye Best-Corrected VA Score
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Time Frame
Baseline to Month 24
Title
Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
Time Frame
Baseline to Month 12, Baseline to Month 24
Title
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
Time Frame
Baseline to Month 12, Baseline to Month 24
Title
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
Time Frame
Baseline to Month 12, Baseline to Month 24
Title
Mean Change From Baseline in Central Retinal Thickness
Time Frame
Baseline to Month 12, Baseline to Month 24
Title
Mean Change From Baseline in Lesion Size
Description
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion
Time Frame
Baseline to Month 12, Baseline to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Hudson, MD
Organizational Affiliation
Retina Centers, PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allen Ho, MD
Organizational Affiliation
Retina Diagnostic & Treatment Associates, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Strong, Ph.D
Organizational Affiliation
QLT Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oscar Cuzzani, MD
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Campbell
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Poway
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Davenport
State/Province
Iowa
Country
United States
City
Missoula
State/Province
Montana
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Portsmouth
State/Province
New Hampshire
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
West Mifflin
State/Province
Pennsylvania
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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