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

University of British Columbia

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00359164

C06-0202

V06-0157

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

new wet AMD

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

1

Active Comparator group

Description:

Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy.

Treatment:

Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab

2

Active Comparator group

Description:

Bevacizumab with verteporfin at Very Low Photodynamic Therapy.

Treatment:

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

3

Sham Comparator group

Description:

Bevacizumab with verteporfin with Sham Photodynamic Therapy.

Treatment:

Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab