Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy.

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.

• Authors: Kelvin Yi Chong Teo, Janice Marie Jordan-Yu, Anna C S Tan, Ian Y S Yeo, Ranjana Mathur, Choi Mun Chan, Tien Yin Wong, Usha Chakravarthy, Chui Ming Gemmy Cheung
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 106 Issue 7 Pg. 987-993 (07 2022) ISSN: 1468-2079 [Electronic] England
• PMID: 33574033 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Angiogenesis Inhibitors
• Recombinant Fusion Proteins
• aflibercept
• Receptors, Vascular Endothelial Growth Factor

Topics

• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Choroid (pathology)
• Female
• Fluorescein Angiography
• Humans
• Intravitreal Injections
• Male
• Polyps (diagnosis, drug therapy)
• Receptors, Vascular Endothelial Growth Factor (therapeutic use)
• Recombinant Fusion Proteins (therapeutic use)
• Tomography, Optical Coherence
• Visual Acuity