Status:
UNKNOWN
Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Oraya Therapeutics, Inc.
Conditions:
Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).
Detailed Description
The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with...
Eligibility Criteria
Inclusion
- Subjects must be age 50 or older
- Women must be post-menopausal ≥1 year or surgically sterilized
- Subjects must have choroidal neovascularization lesion size of ≤11 total disc areas (28.26mm), and a greatest linear dimension of ≤6 mm
- Subjects must have Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye
- Subretinal hemorrhage (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space
Exclusion
- Subjects with prior or concurrent therapies including submacular surgery, thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy and transpupillary thermotherapy (TTT)
- Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy,presence of RPE tears or rips, acute ocular or periocular infection
- Subjects with advanced glaucoma (\>0.8 cup to disk ratio) or intraocular pressure ≥30 mmHg in the study eye
- Previous glaucoma filtering surgery in the study eye
- Refractive error in the study eye demonstrating more than -8 diopters of myopia (or globe axial length ≥26 mm). For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error cannot exceed -8 diopters of myopia
- Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01217762
Start Date
July 1 2008
End Date
October 1 2014
Last Update
January 19 2012
Active Locations (1)
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1
Asociación Para Evitar la Ceguera en México, I.A.P.
Mexico City, Delegación Coyoacán, Mexico, 04030