Macular Degeneration
Conditions
Keywords
AMD, Avastin, Visudyne, Medical condition being studied AMD
Brief summary
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.
Interventions
DRUGVerteporfin Photodynamic Therapy (Low Fluence) and bevacizumab
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.
DRUGVerteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab
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.
DRUGVerteporfin Photodynamic Therapy (SHAM) and bevacizumab
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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
new wet AMD
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed