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

Sponsor:	QLT Inc
Information provided by:	QLT Inc
ClinicalTrials.gov Identifier:	NCT00492284

Purpose

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.

Condition	Intervention	Phase
Choroidal Neovascularization Macular Degeneration	Drug: verteporfin Drug: ranibizumab Drug: dexamethasone	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Verteporfin Ranibizumab Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by QLT Inc:

Primary Outcome Measures:

Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 12 ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

Secondary Outcome Measures:

Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 24 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Central Retinal Thickness [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Lesion Size [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

Enrollment:	162
Study Start Date:	July 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1/4 Fluence Triple Therapy 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	Drug: verteporfin Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds) Other Names: Visudyne photodynamic therapy Drug: ranibizumab 0.5 mg intravitreal injection Other Name: Lucentis Drug: dexamethasone 0.5 mg intravitreal injection
Experimental: 1/2 Fluence Triple Therapy 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	Drug: verteporfin Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds) Other Names: Visudyne photodynamic therapy Drug: ranibizumab 0.5 mg intravitreal injection Other Name: Lucentis Drug: dexamethasone 0.5 mg intravitreal injection
Experimental: 1/2 Fluence Double Therapy Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter	Drug: verteporfin Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds) Other Names: Visudyne photodynamic therapy Drug: ranibizumab 0.5 mg intravitreal injection Other Name: Lucentis
Experimental: Ranibizumab Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter	Drug: ranibizumab 0.5 mg intravitreal injection Other Name: Lucentis

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492284

Show 26 Study Locations

Sponsors and Collaborators

QLT Inc

Investigators

Principal Investigator:	Henry Hudson, MD	Retina Centers, PC
Principal Investigator:	Allen Ho, MD	Retina Diagnostic & Treatment Associates, LLC
Study Chair:	Andrew Strong, Ph.D	QLT Inc
Study Director:	Oscar Cuzzani, MD	QLT Inc

More Information

No publications provided

Responsible Party:	Dr. Oscar Cuzzani, QLT Inc.
ClinicalTrials.gov Identifier:	NCT00492284 History of Changes
Other Study ID Numbers:	BPD OCR 022
Study First Received:	June 25, 2007
Results First Received:	April 13, 2010
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by QLT Inc:

Macular Degeneration
AMD
CNV

Choroidal neovascularization
Photodynamic therapy
CNV Secondary to Age Related Macular Degeneration

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Verteporfin

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012