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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

January 21, 2005
March 11, 2010
December 2004
Not Provided
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
Same as current
Complete list of historical versions of study NCT00102115 on ClinicalTrials.gov Archive Site
Changes in visual performance
Same as current
Not Provided
Not Provided
 
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease

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).

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Degeneration
  • Choroidal Neovascularization
Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
January 2006
Not Provided

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102115
LSCOR-001
Not Provided
Not Provided
Light Sciences LLC
Not Provided
Study Director: Gary Krasner, PhD Light Sciences LLC
Light Sciences LLC
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP