Efficacy of fixed-dosing aflibercept for treating polypoidal choroidal vasculopathy: 1-year results of the VAULT study

Abstract

PurposeTo investigate fixed-dosing aflibercept for treating polypoidal choroidal vasculopathy (PCV).MethodsThis phase IV, prospective, single-arm, interventional case series was conducted in eight centers. Forty treatment-naïve PCV patients were administered three monthly doses of intravitreal aflibercept (2.0 mg) and an injection every 2 months thereafter. Best-corrected visual acuity (BCVA) and central subfield macular thickness (CSMT) were measured at each visit. Fluorescein and indocyanine green angiography (ICGA) were performed at baseline, 3 and 12 months. The primary outcome measure was the proportion of patients who maintained BCVA (<15 letters loss) at 12 months. Changes in BCVA, macular appearance, and polypoidal lesion appearance were also examined.ResultsThirty-five eyes (87.5 %) had maintained BCVA at 12 months. Average BCVA was significantly higher at 12 months (20/53, 64.2 letters) than at baseline (20/80, 55.1 letters, 9-letter gain; P < .001). Mean CSMT was significantly lower at 12 months (253.6 μm) than at baseline (365.2 μm, P < .001). The macula was dry in 32 (76.2 %), 27 (64.3 %), and 24 eyes (60.0 %) at 3, 6, and 12 months respectively. Fourteen eyes (33.3 %) had a fluid recurrence or increase at 6 months, and they had a significantly lower vision gain (P = .005) than other patients at 12 months. Complete polyp regression occurred in 26 eyes (66.7 %) at 12 months.ConclusionsFixed-dosing aflibercept showed favorable outcomes in PCV patients at 12 months. However, some patients had worse outcomes because of fluid recurrence during maintenance dosing, and these patients would require additional treatments.

Aflibercept Treatment in Polypoidal Choroidal Vasculopathy: Results of a Prospective Study in a Caucasian Population

“…On the other hand, ranibizumab monotherapy only demonstrated a 5-letter improvement in the LAPTOP study [10]. Our results are consistent with those of the Vault study, which showed an improvement of 9 letters after 1 year of follow-up in PCV patients treated with bimonthly aflibercept [17]. Our study also showed that VA improvement could be rapidly achieved with a gain of 8.6 letters at 2 months after treatment beginning.…”

“…However, most of the previous studies had been performed in Asian populations since the prevalence of PCV is significantly higher than in the Caucasian population [2, 17, 18]. This study demonstrates clinical and functional outcomes in a Caucasian population comparable to those of Asian populations [17].…”

“…This study demonstrates clinical and functional outcomes in a Caucasian population comparable to those of Asian populations [17]. To our knowledge, this is the largest prospective study performed in a Caucasian population with PCV treated with aflibercept therapy.…”

One-Year Outcomes following Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in Japanese Patients: The APOLLO Study

“…Our BCVA improvement results were very similar to the results of IVA in Japanese PCV patients using a proactive fixed dosing regimen reported by Yamamoto et al [17] . The results of the current study pertaining to the proportion of patients in which BCVA either remained stable or improved (97.6%) were also similar to results reported in the VAULT study in Korea (87.5%) [20] . Our results were also similar to those of the 2q8 regimen group of the VIEW study [15,16] , which included both PCV and typical AMD (95.6%).…”

“…In the VAULT study, Lee et al [20] reported 1-year results of IVA in 40 treatment-naïve PCV patients receiving bimonthly injections after 3 initial monthly injections, and mean BCVA improved from 55.1 to 64.2 letters (ET-DRS chart). They also reported that 87.5% of the patients exhibited maintained or enhanced BCVA at 12 months.…”