Study examines real-world treat-and-extend outcomes and background factors of macular atrophy

Investigators retrospectively evaluated treatment-naïve patients who received a loading dose of a minimum of three monthly intravitreal aflibercept injections, followed by a treat-and-extend regimen. Image credit: ©Titolino – stock.adobe.com

A multicentre study of the outcomes of a treat-and-extend (TAE) regimen using aflibercept (Eylea, Regeneron Pharmaceuticals) showed that the treatment maintained the baseline visual acuity (VA) and reduced the central macular thickness (CMT) for 5 years in Japanese patients with neovascular age-related macular degeneration (nAMD),¹ according to first author Iori Wada, MD, PhD, from the Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, and the Department of Ophthalmology, National Hospital Organization, Kyushu Medical Center, both in Fukuoka, Japan.

Wada was joined in this study by researchers from Fukuoka Dental College, Fukuoka; Juntendo University School of Medicine, Tokyo; Saga University School of Medicine, Saga, Japan; Doheny Eye Institute, Pasadena, California; and the Stein Eye Institute, Los Angeles, California.

The investigators looked at two important factors. The first factor was scope of real-world, long-term outcomes of a TAE regimen, given that large clinical trials of anti-VEGF drugs have reached different conclusions about the various drugs’ abilities to maintain or improve VA.^2-10

Second, they wanted to determine the background factors that contributed to development of macular atrophy after long-term treatment, in that previous studies have reported that long-term anti-VEGF treatment for nAMD has been reported to cause atrophic macular changes, which can cause irreversible visual loss.^11-18

Study cohort and results

The investigators retrospectively evaluated 126 consecutive treatment-naïve patients with nAMD (126 eyes) who received a loading dose of a minimum of three monthly intravitreal aflibercept (IVA) injections that was followed by a TAE. The follow-up was at 5 years. The baseline mean logarithm of the minimum angle of resolution (logMAR) best-corrected VA (BCVA) was 0.42 ± 0.036. The mean CMT was 326.9 ± 10.8 µm, and the greatest linear dimension (GLD) was 4,037.3 ± 188.5 µm.

Of the 126 patients, 63 were followed for 5 years with treatment. “Although the BCVA significantly improved in all cases of total AMD (including type 3 macular neovascularisation [MNV], type 1 or 2 MNV, and polypoidal choroidal vasculopathy) until the first year after treatment, it gradually declined and returned to the baseline levels (P < 0.05). The mean BCVA in all patients declined from 0.42 ± 0.036 logMAR at baseline to 0.36 ± 0.055 logMAR at 5 years,” a difference that did not reach significance, they reported.

The average CMT decreased significantly and was maintained throughout the follow-up period. Multivariable analysis identified the pretreatment GLD as the only independent risk factor for better vision after 5 years of treatment (P = 0.0024).

The study also showed that patients needed fewer injections from the second year and the number gradually decreased during the follow-up period.

The IVA treatment was discontinued in 36 (44%) cases during the follow-up period. However, 12 of these eyes (33%) experienced recurrence; significant recurrence was observed in patients who received a higher total number of aflibercept injections. Macular atrophy was significantly more likely to occur in cases with occult MNV with subretinal hemorrhage than in cases with other forms of nAMD, the authors reported.

Wada and colleagues concluded, “…aflibercept monotherapy using the TAE regimen-maintained baseline VA and reduced CMT for 5 years in Japanese patients with nAMD. A smaller GLD was independently associated with better VA.”

References

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