Department of Ophthalmology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Retina. 2011 Jul-Aug;31(7):1261-7. doi: 10.1097/IAE.0b013e318207d152.
To evaluate the efficacy and safety of a flexible regimen with intravitreal injections of ranibizumab in patients with naive choroidal neovascularization secondary to age-related macular degeneration and to determine whether the final outcome is related to the number of injections.
Prospective, noncomparative, consecutive case series study. We included 90 eyes of 88 patients that were initially treated with 3 consecutive monthly intravitreal injections of ranibizumab, and thereafter, follow-up visits were progressively spread out to a maximum of 8 weeks apart in the absence of visual acuity loss and signs of lesion activity. The primary end points were changes in visual acuity (Early Treatment Diabetic Retinopathy Study letters), foveal thickness measured by spectral-domain optical coherence tomography, and lesion size (LS) measured by fluorescein angiography.
The median visual acuity improved from 53 letters at baseline to 60 letters at Month 1 (P < 0.0001), 63 letters at Month 3 (P < 0.0001), and 60 letters at Month 12 (P < 0.0001). A significant reduction was also observed in foveal thickness and LS (P < 0.0001). The mean number of injections was 4.4, and the mean number of visits was 8.0. Treatment consisted of 3 injections for 40% of patients, and 60% of patients received more than 3 injections. No significant association was observed between the visual acuity improvement and the number of injections. No relevant side effects were observed.
A flexible regimen with ranibizumab therapy is efficacious and safe in patients with neovascular age-related macular degeneration, reducing both the burden of injections and follow-up visits. The visual acuity improvement was independent of the number of injections.
评估玻璃体内注射雷珠单抗灵活方案治疗年龄相关性黄斑变性继发脉络膜新生血管的疗效和安全性,并确定最终结果是否与注射次数有关。
前瞻性、非对照、连续病例系列研究。我们纳入了 88 例 90 只眼,这些患者最初接受了 3 次连续每月的雷珠单抗玻璃体内注射治疗,此后,如果视力没有下降且病变活动无迹象,随访间隔最长可延长至 8 周。主要终点为视力(早期糖尿病视网膜病变研究字母)、频域光学相干断层扫描测量的中心凹厚度和荧光素血管造影测量的病变大小(LS)的变化。
中位视力从基线时的 53 个字母提高到第 1 个月的 60 个字母(P < 0.0001)、第 3 个月的 63 个字母(P < 0.0001)和第 12 个月的 60 个字母(P < 0.0001)。中心凹厚度和 LS 也显著降低(P < 0.0001)。平均注射次数为 4.4 次,平均就诊次数为 8.0 次。40%的患者接受了 3 次注射治疗,60%的患者接受了超过 3 次注射。视力改善与注射次数之间未观察到显著相关性。未观察到明显的不良反应。
雷珠单抗治疗的灵活方案对新生血管性年龄相关性黄斑变性患者有效且安全,减少了注射和随访的负担。视力改善与注射次数无关。