Aflibercept for Radiation Maculopathy (ARM Study): Year-2 Extension of a Prospective Clinical Study.

Abstract

This work describes the 2-year results of the Aflibercept for Radiation Maculopathy (ARM) randomized clinical study that evaluated intravitreal vascular endothelial growth factor antagonist therapy in radiation maculopathy delivering aflibercept using a second-year collapsed, every-6-weeks, treat-and-adjust interval. Forty patients were enrolled in an institutional review board-approved clinical trial and randomly assigned to aflibercept treatment via 1 of 2 regimens: fixed, every-6-week treatment or variable, treat-and-adjust therapy centered around 6 weeks. All patients had a diagnosis of treated uveal melanoma with documented tumor control, and they had visually compromising radiation maculopathy. At conclusion of year 1, the first 30 patients were offered a collapsed single-arm variable of an every-6-weeks treat-and-adjust aflibercept injection schedule for an additional treatment year. Baseline best-corrected visual acuity (BCVA) was 20/63 at ARM study entry 20/62 at the institution of the year-2 extension. At ARM study entry baseline, spectral domain-optical coherence tomography mean central retinal thickness was 432 µm and was 294 µm at the same institution. At the 2-year study's conclusion, 76.7% (23 of 30) of eyes were better than 20/50, and only 6.7% (2 of 30) ended with a BCVA below 20/200. Final mean BCVA was 20/62 and final mean spectral domain-optical coherence tomography central retinal thickness was 286 µm, but as in year 1, this reduction in number of injections was not statistically significant. Aflibercept is effective in treating radiation maculopathy with maintained visual acuity at 2 years but continues to require an ongoing treatment approach to stabilize radiation maculopathy.