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

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab; Drug: Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab; Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab

• Registration Number: NCT00359164
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Primary Completion: 2008-06
• Status Verified: 2008-08
• Study Completion: 2008-08
• Last Update Submitted: 2008-08-12
• Last Update Posted: 2008-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

new wet AMD

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab	Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.
2	Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab	Bevacizumab with verteporfin at Very Low Photodynamic Therapy.
3	Verteporfin Photodynamic Therapy (SHAM) and bevacizumab	Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vancouver General Hospital Eye Care Centre (UBC); 🇨🇦 Vancouver, British Columbia, Canada