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

Macular Degeneration Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492284
• Other study ID #: BPD OCR 022
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2007
• Last updated: May 31, 2011
• Start date: July 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2011
• Source: QLT Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• verteporfin
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
• verteporfin
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
• ranibizumab
0.5 mg intravitreal injection
• dexamethasone
0.5 mg intravitreal injection

Locations

Country	Name	City	State
United States	Retina Centers, PC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
QLT Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1 to Month 12	No
Primary	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	Baseline to Month 12	No
Secondary	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.	Month 1 to Month 24	No
Secondary	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	Baseline to Month 24	No
Secondary	Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline		Baseline to Month 12, Baseline to Month 24	No
Secondary	Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline		Baseline to Month 12, Baseline to Month 24	No
Secondary	Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline		Baseline to Month 12, Baseline to Month 24	No
Secondary	Mean Change From Baseline in Central Retinal Thickness		Baseline to Month 12, Baseline to Month 24	No
Secondary	Mean Change From Baseline in Lesion Size	Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion	Baseline to Month 12, Baseline to Month 24	No