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

Phase 2

Completed

• Conditions: Choroidal Neovascularization; Macular Degeneration
• Interventions: Drug: verteporfin; Drug: ranibizumab; Drug: dexamethasone

• Registration Number: NCT00492284
• Lead Sponsor: QLT Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Study Start: 2007-07
• Primary Completion: 2009-05
• Results First Submitted: 2010-04-13
• Study Completion: 2010-05
• Results First Submitted QC: 2010-05-20
• Results First Posted: 2010-06-22
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1/4 Fluence Triple Therapy	verteporfin	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
1/2 Fluence Double Therapy	ranibizumab	Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
1/4 Fluence Triple Therapy	ranibizumab	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
1/4 Fluence Triple Therapy	dexamethasone	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
1/2 Fluence Triple Therapy	verteporfin	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
1/2 Fluence Triple Therapy	ranibizumab	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
1/2 Fluence Triple Therapy	dexamethasone	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
1/2 Fluence Double Therapy	verteporfin	Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
Ranibizumab	ranibizumab	Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter

Primary Outcome Measures

Name	Time	Method
Mean Number of Retreatments (Day 0 Excluded)	Month 1 to Month 12	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)	Baseline to Month 12	Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

Secondary Outcome Measures

Name	Time	Method
Mean Number of Retreatments (Day 0 Excluded)	Month 1 to Month 24	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	Baseline to Month 24	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	Baseline to Month 12, Baseline to Month 24
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline	Baseline to Month 12, Baseline to Month 24
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline	Baseline to Month 12, Baseline to Month 24
Mean Change From Baseline in Central Retinal Thickness	Baseline to Month 12, Baseline to Month 24
Mean Change From Baseline in Lesion Size	Baseline to Month 12, Baseline to Month 24	Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

Trial Locations

Locations (1)

Retina Centers, PC; 🇺🇸 Tucson, Arizona, United States