title: Efficacy of fixed-dosing aflibercept for treating polypoidal choroidal vasculopathy: 1-year results of the VAULT study.
abstract: OBJECTIVE
  To investigate fixed-dosing aflibercept for treating polypoidal choroidal vasculopathy (PCV).
  
  
  METHODS
  This 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.
  
  
  RESULTS
  Thirty-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.
  
  
  CONCLUSIONS
  Fixed-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.
authors.affiliation: Department of Ophthalmology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.
authors.forename: Joo Eun
authors.initials: JE
authors.lastname: Lee
authors.affiliation: Department of Ophthalmology, Kyungpook National University Hospital, Deagu, South Korea.
authors.forename: Jae Pil
authors.initials: JP
authors.lastname: Shin
authors.affiliation: Department of Ophthalmology, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
authors.forename: Hyun Woong
authors.initials: HW
authors.lastname: Kim
authors.affiliation: Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, South Korea.|Chang's Retina Center, Daegu, South Korea.
authors.forename: Woohyok
authors.initials: W
authors.lastname: Chang
authors.affiliation: Department of Ophthalmology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea.
authors.forename: Yu Cheol
authors.initials: YC
authors.lastname: Kim
authors.affiliation: Department of Ophthalmology, College of Medicine and Institute of Medicine, Kosin University, Busan, South Korea.
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Department of Ophthalmology, Gyeongsang National University School of Medicine, Jinju, South Korea.
authors.forename: In Young
authors.initials: IY
authors.lastname: Chung
authors.affiliation: Department of Ophthalmology, Pusan National University Hospital, #179 Gudeok-ro, Seo-gu, Busan, 602-739, South Korea. jlee@pusan.ac.kr.|Department of Ophthalmology, College of Medicine, Pusan National University, Yangsan, South Korea. jlee@pusan.ac.kr.|Biomedical Research Institute, Pusan National University Hospital, #179 Gudeok-ro, Seo-gu, Busan, 602-739, South Korea. jlee@pusan.ac.kr.
authors.forename: Ji Eun
authors.initials: JE
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002829:Choroid / Q000098:blood supply / Q000473:pathology*; D015862:Choroid Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D009887:Ophthalmoscopy; D011127:Polyps / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor
keywords: Aflibercept; Age-related macular degeneration; Fixed regimen; Polypoidal choroidal vasculopathy