Semeraro Francesco, Russo Andrea, Delcassi Luisa, Romano Mario R, Rinaldi Michele, Chiosi Flavia, Costagliola Ciro
*Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy; †Humanitas Clinical Institute, Milan, Italy; ‡Department of Ophthalmology, Second University of Naples, Naples, Italy; and §Department of Health Sciences, Eye Clinic, University of Molise, Campobasso, Italy.
Retina. 2015 Aug;35(8):1547-54. doi: 10.1097/IAE.0000000000000525.
To evaluate whether ketorolac eyedrops plus intravitreal ranibizumab (IVR) or verteporfin photodynamic therapy plus IVR provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization in age-related macular degeneration.
This was a prospective, randomized, pilot study in 75 patients with naive choroidal neovascularization. Patients were randomized 1:1:1 into 3 groups: ranibizumab monotherapy (RM), ranibizumab plus ketorolac, or ranibizumab plus loading-phase reduced-fluence verteporfin photodynamic therapy (RV) groups.
At 12 months, all groups showed significant improvement in both best-corrected visual acuity and central retinal thickness. The mean best-corrected visual acuity change from baseline to 12 months was -0.14 ± 0.52 logMAR (20/73 ± 20/29), -0.25 ± 0.60 logMAR (20/46 ± 20/27), and -0.10 ± 0.30 (20/97 ± 20/40) logMAR in RM, ranibizumab plus ketorolac, and RV groups, respectively. The mean central retinal thickness change from baseline to 12 months was -125 ± 15 μm, -141 ± 21 μm, and -130 ± 15 μm in RM, ranibizumab plus ketorolac, and RV groups, respectively. Both ranibizumab plus ketorolac and RV groups required fewer IVR treatments than RM.
Compared with RM and ranibizumab plus verteporfin photodynamic therapy, the combination of 0.45% ketorolac eyedrops 3 times a day and ranibizumab in patients with choroidal neovascularization provided superior best-corrected visual acuity and central retinal thickness outcomes. Both combination regimens required fewer IVR injections than RM during the 12-month follow-up period.
评估酮咯酸滴眼液联合玻璃体内注射雷珠单抗（IVR）或维替泊芬光动力疗法联合IVR治疗年龄相关性黄斑变性脉络膜新生血管是否比单纯IVR单药治疗更具优势。
这是一项针对75例初发性脉络膜新生血管患者的前瞻性、随机、试点研究。患者按1:1:1随机分为3组：雷珠单抗单药治疗组（RM）、雷珠单抗联合酮咯酸组、雷珠单抗联合负荷期低剂量维替泊芬光动力疗法组（RV）。
在12个月时，所有组的最佳矫正视力和中心视网膜厚度均有显著改善。RM组、雷珠单抗联合酮咯酸组和RV组从基线到12个月的平均最佳矫正视力变化分别为-0.14±0.52 logMAR（20/73±20/29）、-0.25±0.60 logMAR（20/46±20/27）和-0.10±0.30（20/97±20/40）logMAR。RM组、雷珠单抗联合酮咯酸组和RV组从基线到12个月的平均中心视网膜厚度变化分别为-125±15μm、-141±21μm和-130±15μm。雷珠单抗联合酮咯酸组和RV组所需的IVR治疗次数均少于RM组。
与RM组和雷珠单抗联合维替泊芬光动力疗法相比，每天3次使用0.45%酮咯酸滴眼液联合雷珠单抗治疗脉络膜新生血管患者，在最佳矫正视力和中心视网膜厚度方面效果更佳。在12个月的随访期内，两种联合治疗方案所需的IVR注射次数均少于RM组。
