Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
Department of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.
A randomized clinical trial is needed to evaluate what is the best photodynamic therapy (PDT) protocol to use for acute central serous chorioretinopathy.
To compare the efficacy and safety of a 50% dose of verteporfin (a method of PDT) with the efficacy and safety of a 30% dose for acute central serous chorioretinopathy.
DESIGN, SETTING, AND PARTICIPANTS: A multicenter, noninferiority, double-masked, randomized, controlled, clinical trial in which 131 patients (131 eyes) with acute central serous chorioretinopathy for less than 6 months were recruited with a follow-up of 12 months from university-based ophthalmology practices.
Patients were randomly assigned to either a 50% dose of verteporfin (the 50%-dose PDT group) or a 30% dose (the 30%-dose PDT group).
The 2 primary outcome measures were the proportion of eyes with complete absorption of subretinal fluid and the proportion of eyes with complete disappearance of fluorescein leakage at 6 and 12 months. The secondary outcome measures included the subretinal fluid recurrent rate, the fluorescein leakage recurrent rate at 12 months, the mean best-corrected visual acuity, the retinal thickness of the foveal center, and the maximum retinal thickness at each scheduled visit.
The noninferiority of the 30%-dose PDT compared with the 50%-dose PDT for the primary outcomes was not demonstrated. The optical coherence tomography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (73.8% vs 92.9%; α = 0.0125, P = .006) and at 12 months (75.4% vs 94.6%; α = 0.0125, P = .004). The fluorescein angiography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (68.9% vs 91.1%; α = 0.0125, P = .003) and at 12 months (68.9% vs 92.9%; α = 0.0125, P = .001). The subretinal fluid recurrence rate in the 30%-dose PDT group was greater than that in the 50%-dose PDT group (24.0% vs 5.7% at 12 months; P = .010, determined by use of the log-rank test). The fluorescein leakage recurrent rate in the 30%-dose PDT group was significantly higher than that in the 50%-dose PDT group (16.7% vs 3.8% at 12 months; P = .03, determined by use of the log-rank test). No ocular adverse event was encountered in the study.
A 50% dose of verteporfin may be more effective at resolving subretinal fluid and fluorescein leakage, and with better visual outcomes, than a 30% dose for acute central serous chorioretinopathy.
clinicaltrials.gov Identifier: NCT01574430.
重要性：需要进行一项随机临床试验来评估哪种光动力疗法（PDT）方案最适合急性中心性浆液性脉络膜视网膜病变。
目的：比较 50%浓度维替泊芬（一种 PDT 方法）与 30%浓度维替泊芬治疗急性中心性浆液性脉络膜视网膜病变的疗效和安全性。
设计、地点和参与者：一项多中心、非劣效性、双盲、随机、对照、临床试验，纳入了 131 名（131 只眼）急性中心性浆液性脉络膜视网膜病变时间少于 6 个月的患者，在大学附属眼科诊所进行为期 12 个月的随访。
干预措施：患者随机分配至 50%浓度维替泊芬（50%-剂量 PDT 组）或 30%浓度维替泊芬（30%-剂量 PDT 组）。
主要观察指标：2 项主要观察指标分别为视网膜下液完全吸收的比例和荧光素渗漏完全消失的比例，分别在 6 个月和 12 个月时评估。次要观察指标包括视网膜下液复发率、12 个月时荧光素渗漏复发率、最佳矫正视力均值、中心凹视网膜厚度和每次预约时的最大视网膜厚度。
结果：30%-剂量 PDT 与 50%-剂量 PDT 相比，在主要结局上不具有非劣效性。在 6 个月（73.8%比 92.9%；α=0.0125，P=0.006）和 12 个月（75.4%比 94.6%；α=0.0125，P=0.004）时，基于光学相干断层扫描的改善率在 30%-剂量 PDT 组中低于 50%-剂量 PDT 组。在 6 个月（68.9%比 91.1%；α=0.0125，P=0.003）和 12 个月（68.9%比 92.9%；α=0.0125，P=0.001）时，基于荧光素血管造影的改善率在 30%-剂量 PDT 组中低于 50%-剂量 PDT 组。30%-剂量 PDT 组的视网膜下液复发率高于 50%-剂量 PDT 组（12 个月时为 24.0%比 5.7%；P=0.010，采用对数秩检验）。30%-剂量 PDT 组的荧光素渗漏复发率显著高于 50%-剂量 PDT 组（12 个月时为 16.7%比 3.8%；P=0.03，采用对数秩检验）。研究中未发生眼部不良事件。
结论和相关性：与 30%浓度维替泊芬相比，50%浓度维替泊芬在解决视网膜下液和荧光素渗漏方面可能更有效，且视力结果更好，可用于治疗急性中心性浆液性脉络膜视网膜病变。
试验注册：clinicaltrials.gov 标识符：NCT01574430。
