One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial.

Fenghua Wang,Qing Chang,Mengxi Shen,Ding Xu,Wei Zhang,Guoyou Qin,Fang Wang,Ling Wang,Peiquan Zhao,Yuanzhi Yuan,Qi Zhang,Jingke Zhao,Xiaofeng Ye,Fei Yuan,Xiaodong Sun

doi:10.1155/2019/7530458

Abstract

Purpose. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. Methods. In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. Results. Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344). There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs. −120.5 μm) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066). Conclusion. One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.

Highlights

Neovascular age-related macular degeneration is the fast-growing leading cause of blindness in China among aging population [1–3]
Pro re nata (PRN) regimen after three consecutive monthly loading doses (LD) using optical coherence tomography- (OCT-) guided evaluation has been used widely based on the results of HARBOR and PrONTO study [7, 8]. e Chinese Ocular Fundus Diseases society published the panel advice in Clinical Pathway of Age-Related Macular Degeneration in China [9], which suggested the use of ranibizumab as a loading dose consisting of three initial consecutive injections at monthly intervals followed by OCT-guided retreatment
Both groups showed a significant decrease in central retinal thickness (CRT) from baseline and continued through month 3. e resolution of fluid was sustained from months 3 to 12. e mean CRT reduced from 468 μm at baseline to 327.2 μm at month 3 and 308.7 μm at month 12 in the PRN group

Summary

Introduction

Neovascular age-related macular degeneration (nvAMD) is the fast-growing leading cause of blindness in China among aging population [1–3]. MARINA and ANCHOR study [5, 6] proved that monthly intravitreal injections of ranibizumab can improve the mean best corrected visual acuity (BCVA). Pro re nata (PRN) regimen after three consecutive monthly loading doses (LD) using optical coherence tomography- (OCT-) guided evaluation has been used widely based on the results of HARBOR and PrONTO study [7, 8]. E Chinese Ocular Fundus Diseases society published the panel advice in Clinical Pathway of Age-Related Macular Degeneration in China [9], which suggested the use of ranibizumab as a loading dose consisting of three initial consecutive injections at monthly intervals followed by OCT-guided retreatment. In the CATT study [10], patients in the PRN regimen without initial three-monthly intravitreal injections (as need) showed statistically noninferior mean letters of BCVA compared with the patients receiving the monthly dosing ranibizumab regimen at one-year analysis. It will be interesting to know how this regimen works in Chinese nvAMD patients since 24.5% of them present with polypoidal choroidal vasculopathy (PCV) [11], a much higher prevalence than in Caucasian patients of 9.1% [12]

Methods

Results

Conclusion