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Completed

NCT Number: NCT00359164

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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital Eye Care Centre (UBC)

Vancouver, British Columbia, V5Z 3N9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

new wet AMD

Exclusion criteria

-

Treatment and study plan

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.

Other names: Verteporfin = Visudyne, Bevacizumab = Avastin

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.

Other names: Verteporfin = Visudyne, Bevacizumab = Avastin

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.

Other names: Verteporfin = Visudyne, Bevacizumab = Avastin

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
Aug 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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