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

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Degeneration

Intervention: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab (Drug); Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab (Drug); Verteporfin Photodynamic Therapy (SHAM) and bevacizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Michael Potter, MD, Principal Investigator, Affiliation: The University of British Columbia

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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: 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

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: new wet AMD Exclusion Criteria:

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Locations and Contacts

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

Starting date: July 2006
Last updated: August 12, 2008

Page last updated: August 23, 2015

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