NCT00102115

Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease

Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (planned)
• Sponsor: Light Sciences LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)

Timeline

• Start date: 2004-12-01
• Completion: 2006-01-01
• First posted: 2005-01-24
• Last updated: 2010-03-12

Locations

1 site across 1 country: United States