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).
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 age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Low voltage stereotactic radiotherapy system
Asociación Para Evitar la Ceguera en México, I.A.P.
Mexico City, Delegación Coyoacán, Mexico
Incidence of ocular radiation-related adverse events
Time frame: Month 12
Incidence of ocular adverse events
Time frame: Through month 60
Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA)
Time frame: Month 12
Percentage of subjects gaining ≥ 15 ETDRS letters
Time frame: Month 12
Percentage of subjects gaining ≥ 0 ETDRS letters
Time frame: Month 12
Mean change in ETDRS visual acuity
Time frame: Month 12
Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)
Time frame: Month 12
Mean total number of ranibizumab injections
Time frame: Through month 12 and 24
Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)
Time frame: Month 12
Change in total lesion size by fluorescein angiography (FA)
Time frame: Month 12
Change in central retinal lesion thickness by optical coherence tomography (OCT)
Time frame: Month 12
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Change in central subfield thickness by optical coherence tomography (OCT)
Time frame: Month 12