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

This study has been terminated.
Sponsor:
Information provided by:
Light Sciences LLC
ClinicalTrials.gov Identifier:
NCT00102115
First received: January 21, 2005
Last updated: March 11, 2010
Last verified: December 2005
  Purpose

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).


Condition Intervention Phase
Macular Degeneration
Choroidal Neovascularization
Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Light Sciences LLC:

Primary Outcome Measures:
  • Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD

Secondary Outcome Measures:
  • Changes in visual performance

Estimated Enrollment: 27
Study Start Date: December 2004
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102115

Locations
United States, Texas
Texas Retina
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Light Sciences LLC
Investigators
Study Director: Gary Krasner, PhD Light Sciences LLC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00102115     History of Changes
Other Study ID Numbers: LSCOR-001
Study First Received: January 21, 2005
Last Updated: March 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Light Sciences LLC:
Macular disease
Wet AMD
AMD
Age-Related Macular Disease
PDT
Photodynamic Therapy

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Talaporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 14, 2014