NCT01516294

IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD

A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD) Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis® Treatment as Needed.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Oraya Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion activity and lesion size at 12 months.

Detailed description

This is a single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed to evaluate the efficacy of IRay treatment in patients with PCV as determined by the change in the proportion of lesion activity and lesion size at 12 months.

Conditions

• Polypoidal Chorodial Vasculopathy
• Age Related Macular Degeneration

Interventions

Type	Name	Description
RADIATION	Iray	The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2014-03-01
• First posted: 2012-01-24
• Last updated: 2012-11-01

Locations

1 site across 1 country: Italy