Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 6:19 PM
Study NCT ID:
NCT01516294
Status:
UNKNOWN
Last Update Posted:
2012-11-01
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD
Sponsor:
Oraya Therapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2012-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: