Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy
| العنوان: | Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy |
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| المؤلفون: | Chui Ming Gemmy Cheung, Choi Mun Chan, Tien Yin Wong, Ranjana Mathur, Usha Chakravarthy, Kelvin Yi Chong Teo, Anna C S Tan, Janice Marie Jordan-Yu, Ian Yeo |
| المصدر: | British Journal of Ophthalmology. 106:987-993 |
| بيانات النشر: | BMJ, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, 0301 basic medicine, medicine.medical_specialty, Visual acuity, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, Treat and extend, Lesion, 03 medical and health sciences, Cellular and Molecular Neuroscience, Polyps, 0302 clinical medicine, Ophthalmology, Clinical endpoint, Humans, Medicine, Fluorescein Angiography, Trial registration, Aged, Aflibercept, Choroid, business.industry, Sensory Systems, Clinical trial, Regimen, Receptors, Vascular Endothelial Growth Factor, 030104 developmental biology, Intravitreal Injections, 030221 ophthalmology & optometry, Female, medicine.symptom, business, Tomography, Optical Coherence, medicine.drug |
| الوصف: | PurposeTo compare the efficacy of aflibercept using a personalised versus fixed regimen in treatment-naïve participants with polypoidal choroidal vasculopathy (PCV).DesignA 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 measuresNon-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.ResultsOf 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).ConclusionsPersonalised regimen achieved non-inferior BCVA gain and numerically higher PL closure compared with fixed regimen.Trial registration numberNCT03117634. |
| تدمد: | 1468-2079 0007-1161 0311-7634 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::32c77c16633d3527bbb0ef80dac4295e https://doi.org/10.1136/bjophthalmol-2020-318354 |
| رقم الأكسشن: | edsair.doi.dedup.....32c77c16633d3527bbb0ef80dac4295e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14682079 00071161 03117634 |
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