NCT01521819

Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration

A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Vascularized Pigment Epithelial Detachment (V-PED) Secondary to AMD With Serous Component Superior to 50% of the Lesion 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 is a pilot, single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.

Detailed description

This study will evaluate the efficacy of IRay treatment in patients with Vascularized Pigment Epithelial Detachment (V-PED) with serous component superior to 50% of the lesion as determined by decreasing the lesion activity; by decreasing the number of Lucentis injections required during the 12 month study.

Conditions

• Retinal Pigment Epithelial Detachment With Vascularization
• 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.
DRUG	Lucentis	Intravitreal injection of Lucentis as needed.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2014-08-01
• First posted: 2012-01-31
• Last updated: 2012-10-25

Locations

1 site across 1 country: Italy