Japanese journal of ophthalmology · 2025
Six-year findings of polypoidal choroidal vasculopathy in the EVEREST II study: Japanese subgroup analysis.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Yanagi Yasuo, Mori Ryusaburo, Teo Kelvin Yi Chong, Park Kyu-Hyung, Ngah Nor Fariza, Chen Shih-Jen, Ruamviboonsuk Paisan, Kondo Nagako, Lee Won Ki, Rajagopalan Rajesh, Obata Ryo, Wong Ian Y H, Chee Caroline, Terasaki Hiroko, Sekiryu Tetsuju, Chen Shih-Chou, Lai Timothy Y Y, Cheung Gemmy, Honda Shigeru
Аннотация
PURPOSE: To evaluate long-term outcomes for polypoidal choroidal vasculopathy (PCV) in Japanese patients in the EVEREST II study.
STUDY DESIGN: A multicenter, cross-sectional study of the long-term outcomes of a cohort of patients originally treated with ranibizumab alone (monotherapy group) or in combination with photodynamic therapy PDT (combination group) in the EVEREST II study (ClinicalTrials.gov identifier, NCT01846273).
METHODS: Ninety participants from the six-year EVEREST II follow-up: 20 Japanese and 70 non-Japanese were included. Long-term changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were reported in the Japanese compared to non-Japanese participants. Number of injections, types of anti-vascular endothelial growth factor (VEGF) agents used, and cases with equal visits and injections, indicating fixed dosing or treat-and-extend (TAE) administration were investigated. Outcomes were also compared between those who had verteporfin PDT during the six-year period (n=14) and those who did not (n=6).
RESULTS: The Japanese and non-Japanese participants had similar baseline characteristics. The mean age for Japanese participants was 76±4.47 years, with 25% being women. BCVA improved from baseline to year 2 in both groups (P < 0.05). At six years, BCVA was maintained in the Japanese (67.2 ETDRS letters) but decreased in the non-Japanese participants (from 68.8 to 53.5 letters). The Japanese participants received more injections than the non-Japanese (12.5 vs. 7.57, P=0.017). Aflibercept was the most frequently used anti-VEGF agent, and the number of fixed dosing or TAE administration was higher in the Japanese participants. No significant differences were found in functional and anatomical outcomes between those who received PDT and those who did not (all P > 0.05). However, non-PDT participants had numerically worse BCVA at the final visit.
CONCLUSIONS: This study highlights positive long-term outcomes for Japanese PCV patients and underscores the need for further research to validate these findings in broader patient populations.
STUDY DESIGN: A multicenter, cross-sectional study of the long-term outcomes of a cohort of patients originally treated with ranibizumab alone (monotherapy group) or in combination with photodynamic therapy PDT (combination group) in the EVEREST II study (ClinicalTrials.gov identifier, NCT01846273).
METHODS: Ninety participants from the six-year EVEREST II follow-up: 20 Japanese and 70 non-Japanese were included. Long-term changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were reported in the Japanese compared to non-Japanese participants. Number of injections, types of anti-vascular endothelial growth factor (VEGF) agents used, and cases with equal visits and injections, indicating fixed dosing or treat-and-extend (TAE) administration were investigated. Outcomes were also compared between those who had verteporfin PDT during the six-year period (n=14) and those who did not (n=6).
RESULTS: The Japanese and non-Japanese participants had similar baseline characteristics. The mean age for Japanese participants was 76±4.47 years, with 25% being women. BCVA improved from baseline to year 2 in both groups (P < 0.05). At six years, BCVA was maintained in the Japanese (67.2 ETDRS letters) but decreased in the non-Japanese participants (from 68.8 to 53.5 letters). The Japanese participants received more injections than the non-Japanese (12.5 vs. 7.57, P=0.017). Aflibercept was the most frequently used anti-VEGF agent, and the number of fixed dosing or TAE administration was higher in the Japanese participants. No significant differences were found in functional and anatomical outcomes between those who received PDT and those who did not (all P > 0.05). However, non-PDT participants had numerically worse BCVA at the final visit.
CONCLUSIONS: This study highlights positive long-term outcomes for Japanese PCV patients and underscores the need for further research to validate these findings in broader patient populations.
Предметные рубрики MeSH
AgedAged, 80 and overFemaleHumansMaleAngiogenesis InhibitorsChoroidChoroid DiseasesCross-Sectional StudiesFluorescein AngiographyFollow-Up StudiesFundus OculiIntravitreal InjectionsJapanPhotochemotherapyPhotosensitizing AgentsPolypoidal Choroidal VasculopathyPolypsRanibizumabTime FactorsTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AVerteporfinVisual AcuityEast Asian People