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Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy
  1. Kelvin Yi Chong Teo1,2,3,
  2. Janice Marie Jordan-Yu1,2,
  3. Anna C S Tan1,2,3,
  4. Ian Y S Yeo1,3,
  5. Ranjana Mathur1,3,
  6. Choi Mun Chan1,3,
  7. Tien Yin Wong1,2,3,
  8. Usha Chakravarthy4,
  9. Chui Ming Gemmy Cheung1,2,3
  1. 1Medical Retina, Singapore National Eye Centre, Singapore
  2. 2Retina Research Group, Singapore Eye Research Institute, Singapore
  3. 3Ophthalmology & Visual Sciences Academic Clinical Program (Eye ACP), Duke-NUS Medical School, Singapore
  4. 4Ophthalmology and Vision Sciences, Queen's University Belfast, Belfast, UK
  1. Correspondence to Dr Chui Ming Gemmy Cheung, Medical Retina, Singapore National Eye Centre, Singapore, Singapore, Singapore; gemmy.cheung.c.m{at}singhealth.com.sg

Abstract

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
  • retina
  • imaging
  • treatment other

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Footnotes

  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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