IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD
NCT01516294 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2012-11-01
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.
Conditions
- Polypoidal Chorodial Vasculopathy
- Age Related Macular Degeneration
Interventions
- 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.
Sponsors & Collaborators
-
Oraya Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-03-31
- Completion
- 2014-03-31
Countries
- Italy
Study Locations
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