Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
This study has been terminated.
Sponsor:
Light Sciences LLC
Information provided by:
Light Sciences LLC
ClinicalTrials.gov Identifier:
NCT00102115
First received: January 21, 2005
Last updated: March 11, 2010
Last verified: December 2005
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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 |
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 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 Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013