Shiragami Chieko, Ono Aoi, Kobayashi Mamoru, Manabe Saki, Yamashita Ayana, Shiraga Fumio
Department of Ophthalmology (CS, AO, MK, SM, AY), Kagawa University Faculty of Medicine, Kagawa; and Department of Ophthalmology (FS), Okayama University Medical School, Okayama, Japan.
Medicine (Baltimore). 2014 Oct;93(18):e116. doi: 10.1097/MD.0000000000000116.
Purpose of this study was to evaluate the efficacy of switching to pegaptanib monotherapy for persistent cases of exudative age-related macular degeneration (AMD).Out of 296 eyes of 296 patients treated with ranibizumab or ranibizumab combined with photodynamic therapy (PDT), 50 eyes of 50 AMD patients were found to be resistant to these treatments. Over a 12-month period, intravitreal pegaptanib (IVP) 0.3 mg was administered at intervals of 6 weeks until the exudation disappeared prospectively. All patients were examined with the following tests: best-corrected visual acuity (BCVA) and central retinal thickness (CRT), determined at the initial visit, before the first IVP (baseline), and at 12 months. The factors responsible for achieving dry macula with IVP were examined statistically.The rate of persistent cases with intravitreal ranibizumab (IVR) and/or PDT was 17.0%. The mean number of IVPs administered was 5.4 (range, 2-9). Logarithm of the minimal angle of resolution BCVA at 12 months was stable or improved by ≥ 0.3 in 49 eyes (98.0%), with a significant improvement noted between the baseline and final BCVA (P=0.01, paired t test). The CRT (mean ± standard deviation) was 446.9 ± 150.6 µm at the initial visit, 414.5 ± 146.5 µm at baseline, and 318.7 ± 99.0 µm at 12 months. There was a significant decrease in the mean CRT between the measurements at baseline and at 12 months after the first IVP (P=0.002, Bonferroni correction). At 12 months, the exudative change was completely resolved in 27 eyes (54.0%) and reduced in 21 eyes (42.0%). The number of previous IVR treatments was significantly correlated with dry macula at 12 months.After switching therapy to pegaptanib in persistent cases of AMD, most patients maintained or improved their BCVA and exhibited a positive treatment response at 12 months.
本研究的目的是评估在渗出性年龄相关性黄斑变性（AMD）持续病例中改用培加替尼单药治疗的疗效。在296例接受雷珠单抗或雷珠单抗联合光动力疗法（PDT）治疗的患者的296只眼中，发现50例AMD患者的50只眼对这些治疗耐药。在12个月的时间里，前瞻性地每隔6周玻璃体内注射0.3mg培加替尼（IVP），直到渗出消失。所有患者均接受以下检查：初次就诊时、首次IVP前（基线）以及12个月时测定的最佳矫正视力（BCVA）和中心视网膜厚度（CRT）。对使用IVP实现黄斑干性化的相关因素进行了统计学检查。玻璃体内注射雷珠单抗（IVR）和/或PDT的持续病例发生率为17.0%。IVP的平均注射次数为5.4次（范围为2 - 9次）。49只眼（98.0%）在12个月时的最小分辨角对数BCVA稳定或提高了≥0.3，基线和最终BCVA之间有显著改善（P = 0.01，配对t检验）。初次就诊时CRT（平均值±标准差）为446.9±150.6µm，基线时为414.5±146.5µm，12个月时为318.7±99.0µm。首次IVP后基线测量值与12个月时的平均CRT之间有显著下降（P = 0.002，Bonferroni校正）。在12个月时，27只眼（54.0%）的渗出性改变完全消退，21只眼（42.0%）有所减轻。既往IVR治疗次数与12个月时的黄斑干性化显著相关。在AMD持续病例中改用培加替尼治疗后，大多数患者在12个月时维持或改善了BCVA，并表现出积极的治疗反应。
