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

Tracking Information

First Received Date ^ICMJE

June 25, 2007

Last Updated Date

May 30, 2008

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 6 and Month 12 ]

Change History

Complete list of historical versions of study NCT00492284 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Randomized, Single-Masked Study Comparing Reduced-Fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With CNV Secondary to AMD.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Choroidal Neovascularization
Macular Degeneration

Intervention ^ICMJE

Drug: verteporfin, ranibizumab
Drug: verteporfin, ranibizumab, dexamethasone
Drug: ranibizumab

Study Arms / Comparison Groups

Experimental: Reduced fluence Visudyne followed by Lucentis [within 2 hours]
Experimental: Reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]
Experimental: Very low-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]
Experimental: Lucentis monotherapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00492284

Responsible Party

Dr. Oscar Cuzzani, QLT Inc.

Study ID Numbers ^ICMJE

BPD OCR 022

Study Sponsor ^ICMJE

QLT Inc

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

QLT Inc

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP