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Sponsored by: |
Light Sciences LLC |
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Information provided by: | Light Sciences LLC |
ClinicalTrials.gov Identifier: | NCT00102115 |
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 |
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Macular Degeneration Choroidal Neovascularization |
Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
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 |
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | LSCOR-001 |
Study First Received: | January 21, 2005 |
Last Updated: | December 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00102115 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Macular disease Wet AMD AMD |
Age-Related Macular Disease PDT Photodynamic Therapy |
Photosensitizing Agents Radiation-Sensitizing Agents Talaporfin Metaplasia Eye Diseases Choroid Diseases |
Retinal Degeneration Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
Uveal Diseases Talaporfin Antineoplastic Agents Eye Diseases Physiological Effects of Drugs Choroid Diseases Macular Degeneration Retinal Degeneration Pharmacologic Actions |
Choroidal Neovascularization Photosensitizing Agents Pathologic Processes Radiation-Sensitizing Agents Metaplasia Therapeutic Uses Neovascularization, Pathologic Dermatologic Agents Retinal Diseases |