Clinical trial NCT01217762: Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Official title: A Pilot Study to Evaluate the Safety and Tolerability of the IRay Stereotactic Radiosurgery System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
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
Lead sponsor: Oraya Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ocular radiation-related adverse events
timeFrame: Month 12
Secondary outcomes:
measure: Incidence of ocular adverse events
timeFrame: Through month 60
measure: Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA)
timeFrame: Month 12
measure: Percentage of subjects gaining ≥ 15 ETDRS letters
timeFrame: Month 12
measure: Percentage of subjects gaining ≥ 0 ETDRS letters
timeFrame: Month 12
measure: Mean change in ETDRS visual acuity
timeFrame: Month 12
measure: Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)
timeFrame: Month 12
measure: Mean total number of ranibizumab injections
timeFrame: Through month 12 and 24
measure: Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)
timeFrame: Month 12
measure: Change in total lesion size by fluorescein angiography (FA)
timeFrame: Month 12
measure: Change in central retinal lesion thickness by optical coherence tomography (OCT)
timeFrame: Month 12
measure: Change in central subfield thickness by optical coherence tomography (OCT)
timeFrame: Month 12
Other outcomes:
Locations:
city: Mexico Distrito Federal
country: Mexico
facility: Asociación Para Evitar la Ceguera en México, I.A.P.
state: Delegación Coyoacán
Study officials:
affiliation: Oraya Therapeutics, Inc.
name: Denis O'Shaughnessy, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.