A Phase 1 interventional study of IRay in Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration and Macular Degeneration, sponsored by Oraya Therapeutics, Inc.. Status unknown at 1 site in Mexico. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-01-19.
Sponsored by Oraya Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 62 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Oraya Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
Device: IRay
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
Device: IRay
16 Gy IRay and Lucentis PRN (N = 13)
Device: IRay
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
Device: IRay
Low voltage stereotactic radiotherapy system
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
Change in central subfield thickness by optical coherence tomography (OCT)
Time frame: Month 12
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Oraya Therapeutics, Inc.