Status:
TERMINATED
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
Lead Sponsor:
Light Sciences LLC
Conditions:
Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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).
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00102115
Start Date
December 1 2004
End Date
January 1 2006
Last Update
March 12 2010
Active Locations (1)
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1
Texas Retina
Dallas, Texas, United States, 75231