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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014