视觉结果和眼睛之间的液体变化与多重体冠状血管病接受生物相似CKD-701或参考ranibizumab治疗:一个后 hoc分析3期随机临床试验
Ki Tae Nam1, Cheolmin Yun2, Young Joo Lee2
1Department of Ophthalmology, Jeju National University College of Medicine, Jeju, Korea.
Current eye research
|March 7, 2024
概括
拟议的生物类似药CKD-701在治疗多性胆道血管病变 (PCV) 时,显示出与拉尼比祖马布可比的视觉和解剖结果. 这表明CKD-701是PCV治疗的可行替代方案.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 聚冠状血管病变 (PCV) 是视力丧失的重要原因之一.
- 拉尼比祖马布是标准治疗方法,但生物类似药提供了潜在的成本效益较高的替代方案.
- 评估生物类似药的疗效和安全性对于临床采用至关重要.
研究的目的:
- 为了比较CKD-701的视觉和流体结果,一个拟议的生物类药物,与PCV眼中的参考ranibizumab进行比较.
- 评估CKD-701在改善最佳校正视敏度 (BCVA) 和减少视网膜厚度方面的疗效.
- 评估CKD-701对PCV的颜色上皮质脱落 (PED) 容量和流体特征的影响.
主要方法:
- 一个第三阶段随机临床试验的后期分析.
- 73只PCV眼睛被随机分配给CKD-701 (36只眼睛) 或拉尼比祖马布 (37只眼睛).
- 在三次加重注射后,BCVA,中枢视网膜厚度 (CRT),PED体积和流体特征的平均变化进行比较.
主要成果:
- 平均BCVA变化为CKD-701的+7.50和拉尼比祖马布的+6.32 (p=0.447).
- 在两组之间,CRT和PED体积变化是相似的 (-107.25μm对-96.78μm和-0.22mm3对-0.23mm3).
- 6个月和12个月的液体比例 (视网膜下,视网膜内,视网膜下RPE) 和视觉/解剖变化是可比的.
结论:
- 生物相似的CKD-701单疗法在PCV眼睛中取得了与拉尼比祖马布可比的视觉和解剖结果.
- CKD-701显示出作为PCV的有效和类似的替代治疗的潜力.
- 进一步的研究可能会证实长期的疗效和安全性.
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