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Ophthalmology. 2016 Jun;123(6):1287-96. doi: 10.1016/j.ophtha.2016.02.028. Epub 2016 Apr 13.

Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT): A Phase 3 Randomized Controlled Trial.

Author information

1
School of Medicine, King's College London, London, United Kingdom; Department of Ophthalmology, King's College Hospital, London, United Kingdom. Electronic address: t.jackson1@nhs.net.
2
Department of Ophthalmology, King's College Hospital, London, United Kingdom.
3
School of Medicine, King's College London, London, United Kingdom; Department of Ophthalmology, King's College Hospital, London, United Kingdom.
4
Statistics Collaborative, Inc, Washington, DC.
5
School of Medicine, King's College London, London, United Kingdom; Department of Engineering and Physics, King's College Hospital, London, United Kingdom.
6
Department of Ophthalmology, Maidstone Hospital, Maidstone, United Kingdom.
7
Bristol Eye Hospital, Bristol, United Kingdom.
8
Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.
9
Sunderland Eye Infirmary, Sunderland, United Kingdom, and the Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.
10
Central Angiographic Reading Centre, Queen's University of Belfast, Belfast, United Kingdom.

Abstract

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 mm(2) versus 0.4 mm(2) in the ranibizumab arm (P = 0.27). The CNV size decreased by 0.5 mm(2) in the EMB arm and by 1.3 mm(2) 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.

PMID:
27086023
DOI:
10.1016/j.ophtha.2016.02.028
[Indexed for MEDLINE]
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