NCT00359164

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

A Randomized, Controlled, Double-Masked, Phase II Pilot Study of Visudyne® Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab (Avastin), in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Verteporfin 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.
DRUG	Verteporfin 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.
DRUG	Verteporfin 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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2006-08-01
• Last updated: 2008-08-14

Locations

1 site across 1 country: Canada