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Clinical Trials
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| RADICAL Study |
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone in Combination for AMD lesions (RADICAL)
A Phase II, multicenter, randomized, single-masked study comparing reduced-fluence Visudyne®-Lucentis® combination therapies and Lucentis monotherapy in subjects with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
The purpose of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.
What is Visudyne?
Visudyne is a light activated drug approved for the treatment of certain forms of choroidal neovascularization, or CNV, due to wet AMD, the leading cause of vision loss in people over the age of 55 in North America and Europe.
What is Lucentis?
Lucentis is an anti-VEGF (vascular endothelial growth factor) product approved for the treatment of neovascular wet AMD.
What is Dexamethasone?
Dexamethasone is a corticosteroid that is of interest for inhibiting the inflammatory component of CNV in wet AMD.
What is reduced-fluence?
Reduced fluence refers to using lower light levels than the standard light levels normally used with lasers for Visudyne treatments.
Inclusion Criteria
To be eligible for this study, subjects must fulfill all of the following criteria:
- Treatment naive for choroidal neovascularization (CNV) secondary to AMD in the study eye
- 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
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Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from the study:
- Subfoveal geographic atrophy of 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
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Contact Information
If you, or someone you know, would like to know more about the study and a participating clinic nearest you, please contact the following:
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