Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy. Issue 7 (11th February 2021)

• Record Type: Journal Article
• Authors: Teo, Kelvin Yi Chong; Jordan-Yu, Janice Marie; Tan, Anna C S; Yeo, Ian Y S; Mathur, Ranjana; Chan, Choi Mun; Wong, Tien Yin; Chakravarthy, Usha; Cheung, Chui Ming Gemmy
• Is Part Of: British journal of ophthalmology. Volume 106:Issue 7(2022)
• Page Start: 987
• Page End: 993
• Publication Date: 2021-02-11
• Subjects: clinical trial -- retina -- imaging -- treatment other; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjophthalmol-2020-318354
• Languages: English
• ISSNs: 0007-1161

Abstract

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 .