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, ranibizumab Drug: verteporfin, ranibizumab, dexamethasone Drug: ranibizumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Single-Masked Study Comparing Reduced-Fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With CNV Secondary to AMD.

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

The primary efficacy variable are mean number of retreatments (Day 0 excluded) and mean change from baseline in best-corrected VA score. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

gain = or > 15 letters; VA change = or > 0-letter gain; loss = or > 15 letters; Frequency distribution of VA change; Central retinal thickness--mean and mean change; Lesion size(GLD)--mean and mean change; adverse events, FA assessment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Reduced fluence Visudyne followed by Lucentis [within 2 hours]	Drug: verteporfin, ranibizumab Reduced-fluence Visudyne followed within 2 hours by intravitreal Lucentis 0.5 mg.
2: Experimental Reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]	Drug: verteporfin, ranibizumab, dexamethasone Reduced-fluence Visudyne followed within 2 hours by intravitreal Lucentis 0.5 mg and then dexamethasone 0.5 mg.
3: Experimental Very low-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]	Drug: verteporfin, ranibizumab, dexamethasone Very low-fluence Visudyne followed within 2 hours by intravitreal Lucentis 0.5 mg and then dexamethasone 0.5 mg.
4: Experimental Lucentis monotherapy	Drug: ranibizumab Lucentis monotherapy 0.5 mg, mandatory injection for initial treatment and the first 2 months and then PRN.

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 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 (approx = or <9disc areas [DA])
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA score of 25 - 73 letters (approx 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:	QLT Inc. ( Dr. Oscar Cuzzani )
Study ID Numbers:	BPD OCR 022
Study First Received:	June 25, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00492284 History of Changes
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:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Pathologic Processes
Metaplasia
Therapeutic Uses
Dermatologic Agents
Dexamethasone acetate
Retinal Diseases
Uveal Diseases
Antineoplastic Agents, Hormonal

Eye Diseases
Choroid Diseases
Verteporfin
Gastrointestinal Agents
Retinal Degeneration
Macular Degeneration
Glucocorticoids
Pharmacologic Actions
Choroidal Neovascularization
Photosensitizing Agents
Radiation-Sensitizing Agents
Autonomic Agents
Neovascularization, Pathologic
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009