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Dallas, Texas 75231

  • Choroidal Neovascularization


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).

Study summary:

This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.


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



Primary Contact:

Study Director
Gary Krasner, PhD
Light Sciences LLC

Backup Contact:


Location Contact:

Dallas, Texas 75231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: April 03, 2020

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