Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Study Overview
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Brief Summary
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To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.

Official Title
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Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

Conditions
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Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema

Intervention / Treatment
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* Drug: Bevacizumab
* Device: verteporfin photodynamic therapy reduced fluence
* Device: verteporfin photodynamic therapy standardfluence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are men or women of age 50 or older. Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV). Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography. The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns. Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study. The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion. The CNV is associated with only macular degeneration. Patient defers other approved treatments of subfoveal CNV associated with AMD. Exclusion Criteria: Prior treatment for subfoveal choroidal neovascularization (CNV). Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate. History of vitrectomy or submacular surgery in the study eye. Subretinal fibrosis accounting for more than 50% of the lesion. Non-CNV lesion components account for more than 50% of the total lesion components. CNV due to causes other than AMD. Retinal pigmented epithelial tear involving the center of the macula. Geographic atrophy involving the central macula. Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract). Active intraocular inflammation. Vitreous hemorrhage in the eye. History of spherical equivalent in the study eye greater than negative 8 diopters. Intraocular surgery within 2 months of study enrollment. Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication. History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication. Inability to comply with study or follow-up procedures.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. | Drug: Bevacizumab<br>* Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.<br>* Other names: Avastin, visudyne;Device: verteporfin photodynamic therapy reduced fluence<br>* Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].<br>* Other names: PDT;|
| Experimental: B<br>Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. | Drug: Bevacizumab<br>* Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.<br>* Other names: Avastin, visudyne;Device: verteporfin photodynamic therapy standardfluence<br>* Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT