Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
NCT ID: NCT01217762
Last Updated: 2012-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
62 participants
INTERVENTIONAL
2008-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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11 Gy IRay
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
IRay
Low voltage stereotactic radiotherapy system
16 Gy IRay
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
IRay
Low voltage stereotactic radiotherapy system
16 Gy IRay - Radiation First
16 Gy IRay and Lucentis PRN (N = 13)
IRay
Low voltage stereotactic radiotherapy system
24 Gy IRay
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
IRay
Low voltage stereotactic radiotherapy system
Interventions
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IRay
Low voltage stereotactic radiotherapy system
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
50 Years
ALL
No
Sponsors
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Oraya Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Denis O'Shaughnessy, Ph.D.
Role: STUDY_DIRECTOR
Oraya Therapeutics, Inc.
Locations
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Asociación Para Evitar la Ceguera en México, I.A.P.
Mexico City, Delegación Coyoacán, Mexico
Countries
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References
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Moshfeghi AA, Morales-Canton V, Quiroz-Mercado H, Velez-Montoya R, Zavala-Ayala A, Shusterman EM, Kaiser PK, Sanislo SR, Gertner M, Moshfeghi DM. 16 Gy low-voltage x-ray irradiation followed by as needed ranibizumab therapy for age-related macular degeneration: 12 month outcomes of a 'radiation-first' strategy. Br J Ophthalmol. 2012 Oct;96(10):1320-4. doi: 10.1136/bjophthalmol-2011-301222. Epub 2012 Aug 15.
Other Identifiers
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CLH001
Identifier Type: -
Identifier Source: org_study_id
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