To determine if Visudyne photodynamic therapy (low or very low fluence rate) combined with intravitreal injections of bevacizumab (Avastin) compared with bevacizumab alone will, with similar safety and efficacy, delay time to retreatment with bevacizumab after the initial treatment, in subjects with new wet AMD Hypothesis: PDT in combination with Avastin at either the low or very low fluence rate will delay time to retreatment and reduce the average number of treatments required, compared to Avastin alone, but will have a similar safety and efficacy profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Bevacizumab 1.25 mg with verteporfin at Low Fluence (300 mW/cm2 delivered for 83 seconds \[light dose of 25 J/cm2\]) Photodynamic Therapy. Treatment at Baseline visit, followed by an "as needed" basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham.
Bevacizumab 1.25 mg with verteporfin at Low Fluence (150 mW/cm2 delivered for 83 seconds \[light dose of 12.5 J/cm2\]) Photodynamic Therapy. Treatment at Baseline visit, followed by an "as needed" basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham.
Bevacizumab with SHAM (150 mW/cm2 delivered for 83 seconds \[light dose of 12.5 J/cm2\]) Photodynamic Therapy. Treatment at Baseline visit, followed by an "as needed" basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham.
Vancouver General Hospital Eye Care Centre (UBC)
Vancouver, British Columbia, Canada
To determine if Visudyne therapy (low or very low fluence rate) combined with bevacizumab compared with bevacizumab alone will, with similar safety and efficacy, delay time to retreatment with bevacizumab
To determine if Visudyne therapy (low or very low fluence rate) combined with bevacizumab compared with bevacizumab alone will, with similar safety and efficacy, reduce the average number of bevacizumab treatments
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