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

August 12, 2008 updated by: University of British Columbia

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Vancouver General Hospital Eye Care Centre (UBC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

new wet AMD

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.
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.

Other Names:
  • Verteporfin = Visudyne
  • Bevacizumab = Avastin
Active Comparator: 2
Bevacizumab with verteporfin at Very Low Photodynamic Therapy.
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.

Other Names:
  • Verteporfin = Visudyne
  • Bevacizumab = Avastin
Sham Comparator: 3
Bevacizumab with verteporfin with Sham Photodynamic Therapy.
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.

Other Names:
  • Verteporfin = Visudyne
  • Bevacizumab = Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Michael Potter, MD, The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C06-0202
  • V06-0157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Degeneration

Clinical Trials on Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe