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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab
* Drug: Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab
* Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new wet AMD Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bevacizumab with verteporfin at Low Fluence Photodynamic Therapy. | Drug: Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab<br>* 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.<br>* Other names: Bevacizumab = Avastin;|
| Active Comparator: 2<br>Bevacizumab with verteporfin at Very Low Photodynamic Therapy. | Drug: Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab<br>* 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.<br>* Other names: Bevacizumab = Avastin;|
| Sham Comparator: 3<br>Bevacizumab with verteporfin with Sham Photodynamic Therapy. | Drug: Verteporfin Photodynamic Therapy (SHAM) and bevacizumab<br>* 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.<br>* Other names: Bevacizumab = Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Avastin, Visudyne, Medical condition being studied AMD