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

Not Applicable

• Conditions: Retinal Pigment Epithelial Detachment With Vascularization; Age Related Macular Degeneration
• Interventions: Radiation: Iray; Drug: Lucentis

• Registration Number: NCT01521819
• Lead Sponsor: Oraya Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Study Start: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25
• Primary Completion: 2013-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iray plus Lucentis	Iray	open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.
Iray plus Lucentis	Lucentis	open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.

Primary Outcome Measures

Name	Time	Method
Lesion change as measured with fluorescein angiography.	Baseline and 12 months	Change in the proportion of the lesion which is active at 12 months.

Secondary Outcome Measures

Name	Time	Method
Number of Lucentis injections	Baseline and 12 months	Number of Lucentis injections during 12 months
Visual Acuity change	Baseline and 12 months	Mean change in visual acuity

Trial Locations

Locations (1)

Università Vita-Salute Istituto Scientifico San Raffaele; 🇮🇹 Milano, Italy