Macular epiretinal brachytherapy in treated age-related macular degeneration: MERITAGE study: twelve-month safety and efficacy results
PU Dugel, R Petrarca, M Bennett, A Barak… - Ophthalmology, 2012 - Elsevier
Ophthalmology, 2012•Elsevier
PURPOSE: To evaluate the safety and efficacy of epimacular brachytherapy (EMB) for the
treatment of chronic, active, neovascular age-related macular degeneration (AMD). DESIGN:
Prospective, multicenter, interventional, noncontrolled clinical trial. PARTICIPANTS: Fifty-
three eyes of 53 participants with neovascular AMD requiring frequent anti–vascular
endothelial growth factor (VEGF) retreatment. METHODS: Participants underwent pars plana
vitrectomy with a single 24-Gy dose of EMB delivered using an intraocular, handheld …
treatment of chronic, active, neovascular age-related macular degeneration (AMD). DESIGN:
Prospective, multicenter, interventional, noncontrolled clinical trial. PARTICIPANTS: Fifty-
three eyes of 53 participants with neovascular AMD requiring frequent anti–vascular
endothelial growth factor (VEGF) retreatment. METHODS: Participants underwent pars plana
vitrectomy with a single 24-Gy dose of EMB delivered using an intraocular, handheld …
PURPOSE
To evaluate the safety and efficacy of epimacular brachytherapy (EMB) for the treatment of chronic, active, neovascular age-related macular degeneration (AMD).
DESIGN
Prospective, multicenter, interventional, noncontrolled clinical trial.
PARTICIPANTS
Fifty-three eyes of 53 participants with neovascular AMD requiring frequent anti–vascular endothelial growth factor (VEGF) retreatment.
METHODS
Participants underwent pars plana vitrectomy with a single 24-Gy dose of EMB delivered using an intraocular, handheld cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Optical coherence tomography (OCT) was undertaken monthly, with images assessed by an independent reading center.
MAIN OUTCOME MEASURES
Coprimary outcomes at 12 months were proportion of participants with stable vision (losing <15 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and mean number of anti-VEGF retreatments.
RESULTS
Before enrollment, participants had received an average of 12.5 anti-VEGF injections. After a single treatment with EMB, 81% maintained stable vision, with a mean of 3.49 anti-VEGF retreatments in 12 months. Mean ± standard deviation change in visual acuity was –4.0±15.1 ETDRS letters. Mean ± standard deviation OCT central retinal thickness increased by 50±179 μm. Common adverse events included conjunctival hemorrhage (n = 38), cataract (n = 16), resolving vitreous hemorrhage (n = 6), and eye pain (n = 5).
CONCLUSIONS
Epimacular brachytherapy produces stable visual acuity in most participants with previously treated, active disease. Epimacular brachytherapy may reduce the need for frequent anti-VEGF retreatment. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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