Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
Macular Degeneration, Choroidal Neovascularization
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy
Eligibility Criteria
Inclusion Criteria: Age 50 or older Subject is able to sign informed consent Ability to complete 6 month trial Present with advanced AMD and persistently leaking CNV Adequate hematologic, renal and liver function Negative pregnancy test Subject is able to safely undertake all protocol directed instructions Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse Exclusion Criteria: Concomitant eye disease in eye to be treated Prior ocular radionuclide treatments Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort Subjects with high or pathological myopia with an axial length > 26mm or a refractive error of >/= -8.00D Subjects with glaucoma and vision loss in either eye Subject with a history of other choroidal leakage, e.g. histoplasmosis Subjects with significant media opacity Subjects diagnosed with diabetic retinopathy Subjects who have had eye surgery within the past 3 months Subjects who have received PDT treatment for AMD in the treatment eye Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule Subjects participating in any concurrent trial
Sites / Locations
- Texas Retina