|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Light Sciences LLC |
|---|---|
| Information provided by: | Light Sciences LLC |
| ClinicalTrials.gov Identifier: | NCT00102115 |
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 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 Uveal Diseases 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 |