NCT01217762

Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

A Pilot Study to Evaluate the Safety and Tolerability of the IRay Stereotactic Radiosurgery System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Oraya Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).

Detailed description

The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.

Conditions

• Age-Related Macular Degeneration
• Wet Age-Related Macular Degeneration
• Macular Degeneration
• Eye Diseases
• Retinal Diseases

Interventions

Type	Name	Description
DEVICE	IRay	Low voltage stereotactic radiotherapy system

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-10-01
• Completion: 2014-10-01
• First posted: 2010-10-08
• Last updated: 2012-01-19

Locations

1 site across 1 country: Mexico