Age-Related Macular Degeneration, Eye Diseases, Macular Degeneration, Retinal Diseases, Wet Age-Related Macular Degeneration
Conditions
Keywords
Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiosurgery, radiosurgery, radiotherapy, IRay, AMD, Macular Degeneration, Wet AMD, xray, radiation, x ray, external beam radiation, Ranibizumab, Lucentis
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 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.
Interventions
DEVICEIRay
Low voltage stereotactic radiotherapy system
Sponsors
Oraya Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ocular radiation-related adverse events | Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA) | Month 12 |
| Percentage of subjects gaining ≥ 15 ETDRS letters | Month 12 |
| Percentage of subjects gaining ≥ 0 ETDRS letters | Month 12 |
| Mean change in ETDRS visual acuity | Month 12 |
| Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects) | Month 12 |
| Incidence of ocular adverse events | Through month 60 |
| Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA) | Month 12 |
| Change in total lesion size by fluorescein angiography (FA) | Month 12 |
| Change in central retinal lesion thickness by optical coherence tomography (OCT) | Month 12 |
| Change in central subfield thickness by optical coherence tomography (OCT) | Month 12 |
| Mean total number of ranibizumab injections | Through month 12 and 24 |
Countries
Mexico
Outcome results
None listed