Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration
|ClinicalTrials.gov Identifier: NCT01521819|
Recruitment Status : Unknown
Verified October 2012 by Oraya Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : October 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Retinal Pigment Epithelial Detachment With Vascularization Age Related Macular Degeneration||Radiation: Iray Drug: Lucentis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2014|
U.S. FDA Resources
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.
- Lesion change as measured with fluorescein angiography. [ Time Frame: Baseline and 12 months ]Change in the proportion of the lesion which is active at 12 months.
- Number of Lucentis injections [ Time Frame: Baseline and 12 months ]Number of Lucentis injections during 12 months
- Visual Acuity change [ Time Frame: Baseline and 12 months ]Mean change in visual acuity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521819
|Università Vita-Salute Istituto Scientifico San Raffaele|