Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences LLC
• Treatments: Talaporfin

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