Phase II Pilot Study of Visudyne® Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab.

Sponsor
University of British Columbia
Study ID
NCT00359164
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab — DRUG
    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.
  • Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab — DRUG
    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.
  • Verteporfin Photodynamic Therapy (SHAM) and bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2006
Status verified
Aug 2008
Primary completion
Jun 30, 2008
Completion
Aug 31, 2008

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.
  • Active Comparator: 2
    Bevacizumab with verteporfin at Very Low Photodynamic Therapy.
  • Sham Comparator: 3
    Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Primary Outcome Measure

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

Related Studies