- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102115
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
March 11, 2010 updated by: Light Sciences LLC
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75231
- Texas Retina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
|
Secondary Outcome Measures
Outcome Measure |
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Changes in visual performance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gary Krasner, PhD, Light Sciences LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
January 21, 2005
First Submitted That Met QC Criteria
January 21, 2005
First Posted (Estimate)
January 24, 2005
Study Record Updates
Last Update Posted (Estimate)
March 12, 2010
Last Update Submitted That Met QC Criteria
March 11, 2010
Last Verified
December 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSCOR-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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