Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration
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.
Retinal Pigment Epithelial Detachment With Vascularization
Age Related Macular Degeneration
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Lesion change as measured with fluorescein angiography. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in the proportion of the lesion which is active at 12 months.
- Number of Lucentis injections [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Number of Lucentis injections during 12 months
- Visual Acuity change [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Mean change in visual acuity
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Iray plus Lucentis
open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521819
|Università Vita-Salute Istituto Scientifico San Raffaele|