Wang Tsung-I, Qu Jinfeng, Tang Ran, Shi Xuan, Ying Xin, Tao Ye, Li Xiaoxin
Department of Ophthalmology, Peking University People's Hospital, Beijing, China.
Beijing Key Laboratory of Ocular Disease and Optometry Science, Peking University People's Hospital, Beijing, China.
Eye Vis (Lond). 2025 Jun 18;12(1):24. doi: 10.1186/s40662-025-00441-5.
A post hoc analysis of the STAR study, which was a 48-week, phase IV, multicenter randomized controlled multicenter clinical trial was performed. This study aims to identify the baseline factors associated with visual and anatomic changes over 48 weeks in the treatment of active polypoidal choroidal vasculopathy (PCV) with conbercept.
In the STAR study, 249 participants were randomized to either the 3 + Q12W (3 monthly injections followed by injections every 12 weeks) or 3 + TAE (3 monthly injections followed by treat and extend regimen) group. The association of 27 baseline factors with three outcomes-changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and maximum retinal thickness (MRT) from baseline to 48 weeks-was investigated using univariate regression analysis followed by multivariate linear regression analysis.
The final multivariate model indicated that worse baseline BCVA (P < 0.01), CRT ≤ 400 μm (P < 0.01), fewer polypoidal lesions (P < 0.01), and younger age at baseline (P = 0.04) were associated with greater BCVA gain at week 48. Higher CRT and MRT at baseline were associated with a greater reduction in CRT and MRT at week 48, separately (P < 0.01 and P < 0.01, respectively). Smaller pigment epithelial detachment (PED) volume at baseline was associated with greater reductions in CRT and MRT at week 48 (both P < 0.01). Eyes with relatively good BCVA (> 73 letters) at baseline exhibited lower reductions in CRT and MRT at week 48 (P < 0.01 and P = 0.02, respectively). At week 48, eyes with hemorrhagic PEDs showed greater reductions in CRT and MRT than those with fibrovascular PEDs (P = 0.02 and P = 0.03, respectively). Furthermore, eyes with shallow irregular or sharp-peaked PEDs exhibited greater reductions in CRT (both P < 0.01) and MRT (P = 0.01 and P < 0.01, respectively) than those with multilobular PEDs from baseline to week 48.
In Chinese patients with PCV receiving intravitreal injections of conbercept, baseline characteristics, including age, BCVA, CRT, MRT, number of polypoidal lesions, PED volume, and PED types and morphology, served as predictors of visual and anatomical changes over 48 weeks.
对一项为期48周的IV期多中心随机对照临床试验——STAR研究进行了事后分析。本研究旨在确定在使用康柏西普治疗活动性息肉状脉络膜血管病变（PCV）的48周内，与视力和解剖结构变化相关的基线因素。
在STAR研究中，249名参与者被随机分为3+Q12W组（每3个月注射一次，随后每12周注射一次）或3+TAE组（每3个月注射一次，随后采用治疗并延长方案）。通过单因素回归分析，然后进行多因素线性回归分析，研究了27个基线因素与三个结局指标——从基线到48周最佳矫正视力（BCVA）、中心视网膜厚度（CRT）和最大视网膜厚度（MRT）变化之间的关联。
最终的多因素模型表明，基线BCVA较差（P<0.01）、CRT≤400μm（P<0.01）、息肉样病变较少（P<0.01）以及基线时年龄较小（P=0.04）与48周时BCVA改善更大相关。基线时较高的CRT和MRT分别与48周时CRT和MRT的更大降低相关（分别为P<0.01和P<0.01）。基线时较小的色素上皮脱离（PED）体积与48周时CRT和MRT的更大降低相关（均为P<0.01）。基线时BCVA相对较好（>73个字母）的眼睛在48周时CRT和MRT的降低幅度较小（分别为P<0.01和P=0.02）。在48周时，有出血性PED的眼睛CRT和MRT的降低幅度大于有纤维血管性PED的眼睛（分别为P=0.02和P=0.03）。此外，从基线到48周，与多叶状PED相比，具有浅不规则或尖峰状PED的眼睛CRT（均为P<0.01）和MRT（分别为P=0.01和P<0.01）的降低幅度更大。
在接受玻璃体内注射康柏西普的中国PCV患者中，包括年龄、BCVA、CRT、MRT、息肉样病变数量、PED体积以及PED类型和形态在内的基线特征可作为48周内视力和解剖结构变化的预测指标。
