Who is the sponsor?
Novartis Pharmaceuticals
Who are the patients?
Male or female patients over the age of fifty with AMD The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Inclusion and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments for treatment will be made every month 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 2007
What is the enrollment goal for the sponsor?
Thirty patients
Is the enrollment still open?
No. Is still ongoing at this time.
What is this study investigating?
This is a pilot randomized study using Intravitreal LucentisTM (ranibizumab) either alone or in combination with VisudyneTM (PDT) 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 ranibizumab and verteporfin PDT (reduced fluence) versus treatment with ranibizumab alone in patients with subfoveal CNV due to age-related macular degeneration (AMD).
How is the treatment administered?
Ranibizumab (Lucentis) 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.