Department of Ophthalmology, University of Lausanne, Jules Gonin Eye Hospital, Lausanne, Switzerland.
Br J Ophthalmol. 2014 Sep;98(9):1192-6. doi: 10.1136/bjophthalmol-2013-304556. Epub 2014 Apr 10.
The purpose of this study was to clinically validate an individually planned treatment regimen for neovascular age-related macular degeneration (nAMD), termed, observe and plan. This regimen was based on the predictability of an individual's need for retreatment and aimed to reduce the clinical burden, while obtaining good functional results.
This was a prospective case series that included 104 patients (115 eyes) with treatment-naive nAMD. Following three loading doses of ranibizumab, monthly observation visits allowed the disease recurrence interval to be determined. The recurrence interval was reduced by 2 weeks to give the retreatment interval for the next three injections. Periodical control visits (at least every 6 months) allowed the effectiveness of the treatment to be assessed and individual intervals adjusted.
Mean visual acuity (VA) improved by 8.7 and 9.8 letters in months 3 and 12, respectively. The mean number of injections during the 12-month study was 7.8, while the mean number of ophthalmic examinations between months 3 and 12 was 3.97. The mean treatment interval after the loading doses was 1.97 months.
The observe-and-plan regimen significantly improved VA. This was obtained with fewer clinic visits compared with other regimens, which could ease the burden of nAMD treatment.
Commission cantonale (VD) d'éthique de la recherché Clinique, Université de Lausanne, Protocole 351/11.
本研究旨在对新生血管性年龄相关性黄斑变性（nAMD）的个体化治疗方案进行临床验证，该方案命名为“观察和计划”。该方案基于个体再次治疗需求的可预测性，旨在减少临床负担，同时获得良好的功能结果。
这是一项前瞻性病例系列研究，纳入了 104 名（115 只眼）未经治疗的 nAMD 患者。在接受了 3 次雷珠单抗负荷剂量后，每月进行观察访视以确定疾病复发间隔。将复发间隔缩短 2 周，即为接下来 3 次注射的治疗间隔。定期（至少每 6 个月）进行控制访视，以评估治疗效果并调整个体间隔。
在第 3 个月和第 12 个月，平均视力（VA）分别提高了 8.7 和 9.8 个字母。在 12 个月的研究期间，平均注射次数为 7.8 次，而在第 3 个月至第 12 个月之间，平均眼科检查次数为 3.97 次。负荷剂量后的平均治疗间隔为 1.97 个月。
“观察和计划”方案显著提高了 VA。与其他方案相比，该方案的就诊次数更少，可能会减轻 nAMD 治疗的负担。
瑞士洛桑大学州伦理委员会（VD），研究方案 351/11。
