Overview

This trial is active, not recruiting.

Conditions age-related macular degeneration, wet age-related macular degeneration, macular degeneration, eye diseases, retinal diseases
Treatment iray
Phase phase 1
Sponsor Oraya Therapeutics, Inc.
Start date July 2008
End date October 2010
Trial size 62 participants
Trial identifier NCT01217762, CLH001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
iray
Low voltage stereotactic radiotherapy system
(Experimental)
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
iray
Low voltage stereotactic radiotherapy system
(Experimental)
16 Gy IRay and Lucentis PRN (N = 13)
iray
Low voltage stereotactic radiotherapy system
(Experimental)
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
iray
Low voltage stereotactic radiotherapy system

Primary Outcomes

Measure
Incidence of ocular radiation-related adverse events
time frame: Month 12

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Oraya Therapeutics, Inc..