AMD STUDY – Avastin and PDT for AMD

Who is the sponsor?
California Retina Research Foundation

Who are the patients?
Male or female patients over the age of fifty years with wet macular degeneration. The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.

How long is the trial?
Assessments for treatment will be made every 4-6 weeks for a period of 12 months. Then safety visits will follow between months 12 through 24.

When did participation agreement start at our site?
June 2006

What is the enrollment goal for the sponsor?
Twenty-five patients.

What is this study investigating?
This is a Phase II randomized study using intravitreal bevacizumab (Avastin) in combination with Visudyne-Photodynamic Therapy for the treatment of neovascular age-related macular degeneration (AMD) with the following objective: To evaluate safety, visual acuity (VA) outcomes, persistence of choroidal neovascular (CNV) leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin PDT (standard or reduced fluence) in patients with subfoveal CNV due to age-related macular degeneration (AMD).

How is the treatment administered?
Bevacizumab is administered as an injection into the eye. Photodynamic therapy with Visudyne is a two-step process in which a special dye called Visudyne is injected into a vein in your hand or arm. The dye accumulates in the abnormal vessels beneath the macula. At this point, using specialized ophthalmic equipment and lenses, a low-powered laser is focused onto the damaged area to activate the chemical dye and promote closure of the abnormal vessels.