Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT) A Phase 3 Randomized Controlled Trial Presented in part at: Retina Day, American Academy of Ophthalmology Annual Meeting, November 2015, Las Vegas, Nevada

Autor: Jackson, T.L., Desai, R., Simpson, A., Neffendorf, J.E., Petrarca, R., Smith, K., Wittes, J., Lewis, C., Membrey, L., Haynes, R., Costen, M., Steel, D.H.W., Muldrew, A., Chakravarthy, U.
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Male
Vascular Endothelial Growth Factor A
Conference Paper
retina
genetic structures
visual acuity
very elderly
Brachytherapy
Angiogenesis Inhibitors
Vitrectomy
middle aged
Macula Lutea
strontium
salvage therapy
Fluorescein Angiography
Aged
80 and over

VEGFA protein
human
age related macular degeneration

clinical trial
aged
vitreous floaters
retina hemorrhage
female
endophthalmitis
priority journal
cataract
monotherapy
Intravitreal Injections
uveitis
Strontium Radioisotopes
retina macula lutea
Tomography
Optical Coherence

epimacular brachytherapy
radiation response
subretinal neovascularization
neovascular age related macular degeneration
visual disorder
blurred vision
Ranibizumab
Humans
controlled study
human
procedures
Radiation Injuries
antagonists and inhibitors
wet macular degeneration
Aged

optical coherence tomography
vitreous hemorrhage
phase 3 clinical trial
retina detachment
fluorescence angiography
visual acuity reduction
intravitreal drug administration
major clinical study
eye diseases
angiogenesis inhibitor
multicenter study
confidence interval
vasculotropin A
randomized controlled trial
Chronic Disease
adverse effects
Wet Macular Degeneration
sense organs
Zdroj: Jackson, T L, Desai, R, Simpson, A, Neffendorf, J E, Petrarca, R, Smith, K, Wittes, J, Lewis, C, Membrey, L, Haynes, R, Costen, M, Steel, D H W, Muldrew, A & Chakravarthy, U 2016, ' Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT) A Phase 3 Randomized Controlled Trial Presented in part at: Retina Day, American Academy of Ophthalmology Annual Meeting, November 2015, Las Vegas, Nevada. ', Ophthalmology, vol. 123, no. 6, pp. 1287-1296 . https://doi.org/10.1016/j.ophtha.2016.02.028
DOI: 10.1016/j.ophtha.2016.02.028
Popis: Purpose To assess the safety and efficacy of epimacular brachytherapy (EMB) for patients with chronic, active, neovascular age-related macular degeneration (AMD). Design Phase 3 randomized controlled trial. Participants Patients (n = 363) with neovascular AMD already receiving intravitreal ranibizumab injections. Intervention Either pars plana vitrectomy with 24-gray EMB and ongoing pro re nata (PRN) ranibizumab (n = 224) or ongoing PRN ranibizumab monotherapy (n = 119). Main Outcome Measures The coprimary outcomes, at 12 months, were the number of PRN ranibizumab injections and Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (VA). Secondary outcomes included the proportion of participants losing fewer than 15 ETDRS letters, angiographic total lesion size, choroidal neovascularization (CNV) size, and optical coherence tomography (OCT) foveal thickness. A predefined subgroup analysis tested the influence of baseline ocular characteristics on the response to EMB. Results The mean number of PRN ranibizumab injections was 4.8 in the EMB arm and 4.1 in the ranibizumab monotherapy arm (P = 0.068). The mean VA change was -4.8 letters in the EMB arm and -0.9 letters in the ranibizumab arm (95% confidence interval of difference between groups, -6.6 to -1.8 letters). The proportion of participants losing fewer than 15 letters was 84% in the EMB arm and 92% in the ranibizumab arm (P = 0.007). In the EMB arm, the mean total lesion size increased by 1.2 mm2 versus 0.4 mm2 in the ranibizumab arm (P = 0.27). The CNV size decreased by 0.5 mm2 in the EMB arm and by 1.3 mm2 in the ranibizumab arm (P = 0.27). The OCT foveal thickness decreased by 1.0 μm in the EMB arm and by 15.7 μm in the ranibizumab arm (P = 0.43). Most subgroups favored ranibizumab monotherapy, some significantly so. One participant showed retinal vascular abnormality attributed to radiation, but otherwise safety was acceptable. Conclusions These results do not support the use of EMB for chronic, active, neovascular AMD. Safety is acceptable out to 12 months, but radiation retinopathy can occur later, so further follow-up is planned.
Databáze: OpenAIRE