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

NCT00359164 | Completed Phase 2

• 2 other identifiers: C06-0202V06-0157
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

AMD; Avastin; Visudyne; Medical condition being studied AMD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.

Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab

2

ACTIVE COMPARATOR

Bevacizumab with verteporfin at Very Low Photodynamic Therapy.

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

3

SHAM COMPARATOR

Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab

Interventions

Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab DRUG

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.

Also known as: Verteporfin = Visudyne, Bevacizumab = Avastin

1

Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab DRUG

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.

Also known as: Verteporfin = Visudyne, Bevacizumab = Avastin

2

Verteporfin Photodynamic Therapy (SHAM) and bevacizumab DRUG

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.

Also known as: Verteporfin = Visudyne, Bevacizumab = Avastin

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• new wet AMD

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital Eye Care Centre (UBC)

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab; Verteporfin; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Michael Potter, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 14, 2008

Record last verified: 2008-08

Locations

CA (1)