Negligible Rebound in Myopia Progression Following Cessation of Treatment with 0.01% Atropine for 3 years: Year-4 Results from the CHAMP Phase 3 Clinical Trial.

INTRODUCTION

Stage 2 of the Childhood Atropine for Myopia Progression (CHAMP) study was conducted to observe the safety, efficacy and rebound effects of low-dose atropine sulphate ophthalmic solutions (0.01% and 0.02%) for paediatric myopia in the year following cessation of 3 years of prior treatment.

METHODS

The study was a multicentre, randomised, double-masked, placebo-controlled Phase 3 clinical trial. Children aged 3 to < 17 years with myopia (spherical equivalent refractive error (SER) from -0.50 to -6.00 D) who entered and completed Stage 1 (3 years of treatment) participated in the fourth-year follow-up (Stage 2). Stage 1 participants who were treated with atropine 0.01% or 0.02% were re-randomised 1:1:1 to atropine 0.01%, atropine 0.02% or vehicle in Stage 2. Stage 1 vehicle-treated participants were re-randomised 1:1 to atropine 0.01% or atropine 0.02% in Stage 2. Outcomes included changes in cycloplegic SER, changes in axial length (AL), responder status continuity and progression to high myopia.

RESULTS

Four hundred and twenty participants were randomised in Stage 2. Negligible rebound was observed among the participants who switched from 0.01% atropine to vehicle compared to those who continued on 0.01% atropine treatment (least square mean difference in SER change from Month 36 to Month 48 between continued treatment and switching to vehicle = 0.019 D, 95% CI [-0.14, 0.18], p = 0.82 for the modified Intent to Treat set). Stage 1 responders remained responders in 83-90% of participants in various Stage 2 groups. Safety profiles were favourable, with mild, transient adverse events.

CONCLUSIONS

Atropine sulphate ophthalmic solution (0.01%) exhibited negligible rebound in myopia progression after treatment cessation following 3 years of continued treatment, highlighting its potential as a treatment option. The treatment maintained a favourable safety record, and the overall benefit and risk assessment support its potential use as a long-term myopia management option.

CLINICAL TRIAL REGISTRATION: The Childhood Atropine for Myopia Progression (CHAMP) study was registered in clinicaltrials.gov (NCT03350620, registration date November 17, 2017).