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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab
Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab
Verteporfin Photodynamic Therapy (SHAM) and bevacizumab
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Avastin, Visudyne, Medical condition being studied AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: new wet AMD Exclusion Criteria: -

Sites / Locations

  • Vancouver General Hospital Eye Care Centre (UBC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

1

2

3

Arm Description

Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.

Bevacizumab with verteporfin at Very Low Photodynamic Therapy.

Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
July 28, 2006
Last Updated
August 12, 2008
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00359164
Brief Title
Phase II Pilot Study of Visudyne® Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab.
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Avastin, Visudyne, Medical condition being studied AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Bevacizumab with verteporfin at Very Low Photodynamic Therapy.
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Bevacizumab with verteporfin with Sham Photodynamic Therapy.
Intervention Type
Drug
Intervention Name(s)
Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab
Other Intervention Name(s)
Verteporfin = Visudyne, Bevacizumab = Avastin
Intervention Description
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
Intervention Name(s)
Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab
Other Intervention Name(s)
Verteporfin = Visudyne, Bevacizumab = Avastin
Intervention Description
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
Intervention Name(s)
Verteporfin Photodynamic Therapy (SHAM) and bevacizumab
Other Intervention Name(s)
Verteporfin = Visudyne, Bevacizumab = Avastin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: new wet AMD Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Potter, MD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital Eye Care Centre (UBC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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