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.
Highlights
Polypoidal choroidal vasculopathy (PCV) is a subtype of exudative age-related macular degeneration (AMD) that can cause permanent vision loss due to hemorrhage, exudation, macular edema, and disciform scar formation
Visual acuity was not maintained with photodynamic therapy (PDT) treatment over the long term [9, 10] and eyes treated with ranibizumab had better functional outcomes than eyes treated with PDT after 1 year [11, 12]
Subjects were considered for participation if all of the following were true: diagnosed with the PCV subtype of exudative AMD via indocyanine green angiography (ICGA), polypoidal lesion located within 3,000 μm of the foveal center, and best-corrected visual acuity (BCVA) between 20/40 and 20/320
Summary
Polypoidal choroidal vasculopathy (PCV) is a subtype of exudative age-related macular degeneration (AMD) that can cause permanent vision loss due to hemorrhage, exudation, macular edema, and disciform scar formation. This type of AMD has been reported to account for approximately 10 % of exudative AMD cases in Western populations [1] and approximately 50 % of exudative AMD cases in Asian populations [2]. Anti-VEGF treatment seems more promising than PDT. The VEGF Trap-Eye Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies demonstrated that aflibercept is effective for treating wet AMD as ranibizumab, but it has a longer treatment interval [13]. Several studies have shown that treatment of PCV with aflibercept results in good functional results and, frequently, polyp closure [14,15,16,17]
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