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

Macular Degeneration Clinical Trial

Official title:

Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00102115
• Other study ID #: LSCOR-001
• Status: Terminated
• Phase: Phase 1
• First received: January 21, 2005
• Last updated: March 11, 2010
• Start date: December 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2005
• Source: Light Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
United States	Texas Retina	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Light Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
Secondary	Changes in visual performance

External Links

•   Study sponsor