Study of Talaporfin Sodium Photodynamic Therapy to Treat 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).
Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
|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|
- Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
- Changes in visual performance
|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.