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

NCT ID: NCT00359164

Last Updated: 2008-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Macular Degeneration

Keywords

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AMD Avastin Visudyne Medical condition being studied AMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.

Group Type ACTIVE_COMPARATOR

Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab

Intervention Type 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.

2

Bevacizumab with verteporfin at Very Low Photodynamic Therapy.

Group Type ACTIVE_COMPARATOR

Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab

Intervention Type 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.

3

Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Group Type SHAM_COMPARATOR

Verteporfin Photodynamic Therapy (SHAM) and bevacizumab

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Verteporfin = Visudyne Bevacizumab = Avastin Verteporfin = Visudyne Bevacizumab = Avastin Verteporfin = Visudyne Bevacizumab = Avastin

Eligibility Criteria

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Inclusion Criteria

new wet AMD

Exclusion Criteria

\-
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Michael Potter, MD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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Vancouver General Hospital Eye Care Centre (UBC)

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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V06-0157

Identifier Type: -

Identifier Source: secondary_id

C06-0202

Identifier Type: -

Identifier Source: org_study_id