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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359164
First Posted: August 1, 2006
Last Update Posted: August 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of British Columbia
  Purpose
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.

Condition Intervention Phase
Macular Degeneration Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab Drug: Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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

Estimated Enrollment: 36
Study Start Date: July 2006
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

new wet AMD

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359164


Locations
Canada, British Columbia
Vancouver General Hospital Eye Care Centre (UBC)
Vancouver, British Columbia, Canada, V5Z 3N9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Michael Potter, MD The University of British Columbia
  More Information

Responsible Party: Dr. Michael Potter, University of British Columbia
ClinicalTrials.gov Identifier: NCT00359164     History of Changes
Other Study ID Numbers: C06-0202
V06-0157
First Submitted: July 28, 2006
First Posted: August 1, 2006
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by University of British Columbia:
AMD
Avastin
Visudyne
Medical condition being studied AMD

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Bevacizumab
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents