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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102115
Recruitment Status : Terminated
First Posted : January 24, 2005
Last Update Posted : March 12, 2010
Information provided by:
Light Sciences LLC

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Changes in visual performance

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00102115

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

Additional Information:
Layout table for additonal information Identifier: NCT00102115    
Other Study ID Numbers: LSCOR-001
First Posted: January 24, 2005    Key Record Dates
Last Update Posted: March 12, 2010
Last Verified: December 2005
Keywords provided by Light Sciences LLC:
Macular disease
Age-Related Macular Disease
Photodynamic Therapy
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents