Sun Zuhua, Gong Yuanyuan, Yang Yating, Huang Ying, Yu Suqin, Pei Junqing, Lin Bing, Zhou Rong, Li Yingzi, Li Yumin, Zhang Junyan, Liu Xiaoling
School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.
Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Med (Lausanne). 2022 Feb 9;8:791935. doi: 10.3389/fmed.2021.791935. eCollection 2021.
To compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).
Multicenter, randomized, non-inferiority clinical trial.
Naïve PCV patients.
Patients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. At baseline, patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group.
Non-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above -5 letters).
Eighty-six patients were enrolled, with 43 in each group. At month 12, the change of BCVA in initial combination group was equivalent to that in the delayed combination group, with gains of 6.42 ± 1.89 and 7.49 ± 2.14 (mean ± standard error) letters, respectively [delayed group minus initial group: 1.07 letters; 95% confidence interval (CI): -4.62 to 6.76; = 0.0198]. The rates of complete polyp regression were 66.67 and 45.83% in the initial and delayed combination groups, respectively. The difference was not statistically significant ( = 0.386). The mean reductions of CRT were 204.77 ± 28.79 and 84.14 ± 30.62 μm in each group respectively. The difference was statistically significant ( = 0.005). In addition, the mean injection numbers were 3.47 ± 2.39 and 4.91 ± 2.65 in each group respectively. The differences were statistically significant ( = 0.010).
There was effective in both groups in patients with PCV. The initial combination group showed a more efficient decrease in CRT and polyp regression, along with fewer injections. However, the initial combination group was non-inferior compared with the delayed combination group in terms of the improvement of BCVA.
https://ClinicalTrials.gov, Identifier: NCT02821520.
比较初始光动力疗法（PDT）联合玻璃体内注射康柏西普（IVC）与延迟光动力疗法联合玻璃体内注射康柏西普治疗息肉状脉络膜血管病变（PCV）的疗效。
多中心、随机、非劣效性临床试验。
初治PCV患者。
患者按1:1随机分为两组：初始PDT联合IVC组和延迟PDT联合IVC组。基线时，初始联合组患者在1周内接受PDT和IVC治疗，而延迟联合组患者仅接受IVC治疗。随访期间，每组根据需要给予PDT和IVC。
延迟PDT联合IVC相对于初始PDT联合IVC在最佳矫正视力从基线到第12个月的平均变化方面的非劣效性（差异的95%置信区间完全高于-5个字母）。
共纳入86例患者，每组43例。在第12个月时，初始联合组的最佳矫正视力变化与延迟联合组相当，分别提高了6.42±1.89和7.49±2.14（平均值±标准误）个字母[延迟组减去初始组：1.07个字母；95%置信区间（CI）：-4.62至6.76；P = 0.0198]。初始联合组和延迟联合组的息肉完全消退率分别为66.67%和45.83%。差异无统计学意义（P = 0.386）。每组中央视网膜厚度（CRT）的平均降低值分别为204.77±28.79和84.14±30.62μm。差异有统计学意义（P = 0.005）。此外，每组的平均注射次数分别为3.47±2.39和4.91±2.65。差异有统计学意义（P = 0.010）。
两组对PCV患者均有效。初始联合组在降低CRT和息肉消退方面更有效，且注射次数更少。然而，在最佳矫正视力改善方面，初始联合组与延迟联合组相比非劣效。
