Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD) — ASaP  

Age-Related Macular Degeneration Clinical Trial

Official title: Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)

Status Completed

Clinical Trial Summary

The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD

Clinical Trial Description

Age-related macular degeneration (AMD) is the leading cause of blindness for individuals over fifty-five years of age that live in the industrialized world. It affects 5-10 million people in the US and as many as 30 million worldwide. There are two forms of the disease, both of which cause a loss of central vision. Approximately eighty-five percent of patients have the less severe dry form that produces gradual but rarely complete vision loss. The remaining fifteen percent have the severe wet, or exudative, form that causes rapid, disabling blindness. Wet AMD is further characterized by choroidal neovascularization (CNV), a growth under the macula of abnormal blood vessels originating from the choroidal capillary bed. Research has linked chronic inflammation to both forms of AMD.

Only recently, unrestrained complement activation was identified in genetic studies to be one of the key mechanisms in the pathogenesis of AMD. It has also been demonstrated that complement activation plays a crucial role in the development of CNV. Therefore, the use of intravitreal complement inhibitors may be beneficial in participants subjects with neovascular AMD.

This prospective, uncontrolled, non-randomized, dose-escalating, pilot Phase I study will provide initial safety and tolerability information on intravitreal complement inhibitor (POT-4) therapy in AMD patients with subfoveal CNV. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

• NCT number: NCT00473928
• Study type: Interventional
• Source: Potentia Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 2007
• Completion date: February 2010