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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Bevacizumab

U.S. FDA Resources

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 [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

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 [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

new wet AMD

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Dr. Michael Potter, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00359164 History of Changes
Other Study ID Numbers:	C06-0202, V06-0157
Study First Received:	July 28, 2006
Last Updated:	August 12, 2008
Health Authority:	Canada: Health Canada

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
Verteporfin
Bevacizumab

Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013