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

NCT00102115 | Terminated Phase 1

• 1 other identifier: LSCOR-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Macular Degeneration; Choroidal Neovascularization

Keywords

Macular disease; Wet AMD; AMD; Age-Related Macular Disease; PDT; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD

Secondary Outcomes (1)

• Changes in visual performance

Interventions

Talaporfin Sodium (LS11) Photodynamic Therapy (PDT) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Light Sciences LLC: lead

Study Sites (1)

Texas Retina

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Talaporfin; Photochemotherapy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Gary Krasner, PhD

  Light Sciences LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2005
• First Posted: January 24, 2005
• Study Start: December 1, 2004
• Study Completion: January 1, 2006
• Last Updated: March 12, 2010

Record last verified: 2005-12

Locations

US (1)