Purpose To compare the efficacy of aflibercept using a personalised versus fixed regimen in treatment-naïve participants with polypoidal choroidal vasculopathy (PCV).
Design A 52-week, randomised, open-label, non-inferiority, single-centre study that included participants with symptomatic PCV. Participants were randomised (3:1 ratio) to receive either personalised (n=40) or fixed 8-weekly treatment regimen (n=13). The personalised regimen allowed for either early treat and extend (T&E) after week 12 or late T&E with 3 additional 4-weekly aflibercept injections until week 24 in participants with residual polypoidal lesions (PL) on indocyanine green angiography (ICGA) at week 12.
Main outcomes and measures Non-inferiority of personalised to fixed regimen for mean change in best-corrected visual acuity (BCVA) from baseline to week 52 (non-inferiority margin: −5 letters). The key secondary outcomes include reduction in central subfield thickness (CSFT) on optical coherence tomography and the anatomical closure of PL on ICGA.
Results Of the 53 participants, the mean (SD) age was 69.2 (8.1) years, 19 (35.8 %) were male. Personalised group was non-inferior to fixed for the primary end point (+8.1 vs +7.9 letters at week 52, respectively; difference 0.16, 95% CI −2.8 to 2.4, p=0.79). There was greater reduction in mean CSFT (SD) in the personalised versus fixed group (−248.8 (169.9) vs −164.8 (148.9) µm, p=0.03). Closure of PL occurred in 21 (55.2%) and 5 (41.6%) of study eyes in personalised and fixed groups, respectively at week 52 (p=0.41).
Conclusions Personalised regimen achieved non-inferior BCVA gain and numerically higher PL closure compared with fixed regimen.
Trial registration number NCT03117634.
- clinical trial
- treatment other
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Contributors KYCT and CMGC designed the study, collected the data, interpreted the findings and drafted the final manuscript. JMJ-Y interpreted the data and contributed to the drafting of the final manuscript. ACST, IYSY, RM, CMC and TYW contributed to collection of data and the review and drafting of the final manuscript. UC contributed to the interpretation of data and the review and drafting of the final manuscript.
Funding National Medical Research Council Singapore Open Fund Large Collaborative Grant: NMRC/LCG/004/2018. This study was in investigator initiated study with partial funding supported by Bayer (no funding or grant number). Bayer was not involved in the study design, data collection, data interpretation and drafting of this manuscript.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The trial was approved by the Sing health Centralised institutional review board (Singhealth CIRB Ref. No. 2017/2331 SERI Ref. No. R1448/31/2017) and conducted according to the tenets of the Declaration of Helsinki. Written informed consent was provided by all subjects prior to their participation in the trial.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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