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

Light Sciences Oncology

Status and phase

Terminated

Phase 1

Conditions

Choroidal Neovascularization

Macular Degeneration

Treatments

Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102115

LSCOR-001

Details and patient eligibility

About

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).

Full description

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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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