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

NCT ID: NCT00102115

Last Updated: 2010-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-01-31

Brief 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).

Detailed 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.

Conditions

Macular Degeneration; Choroidal Neovascularization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Light Sciences LLC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gary Krasner, PhD

Role: STUDY_DIRECTOR

Light Sciences LLC

Locations

Texas Retina

Dallas, Texas, United States

Countries

United States

Other Identifiers

LSCOR-001

Identifier Type: -

Identifier Source: org_study_id