2
Clinical Trials associated with KH658A Phase I/II Study to Evaluate the Tolerability, Safety and Efficacy of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD).
KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
Start Date28 Jun 2024 |
Sponsor / Collaborator- |
KH658眼用注射液在新生血管性(湿性)年龄相关性黄斑变性(nAMD)患者中的耐受性、安全性和疗效探索性I/II期临床试验
[Translation] Phase I/II clinical trial to investigate the tolerability, safety and efficacy of KH658 ophthalmic injection in patients with neovascular (wet) age-related macular degeneration (nAMD)
I期(剂量递增)
评估脉络膜上腔注射不同剂量KH658眼用注射液在新生血管性(湿性)年龄相关性黄斑变性(nAMD)患者中的耐受性和安全性,初步评估KH658眼用注射液治疗nAMD的疗效。
II期(疗效探索)
根据I期耐受性、安全性和初步疗效评估的结果选择2个KH658眼用注射液剂量,以玻璃体腔内注射阿柏西普为阳性对照,评估KH658眼用注射液在nAMD患者中的疗效和安全性。
[Translation] Phase I (dose escalation)
Evaluate the tolerability and safety of different doses of KH658 ophthalmic injection injected into the suprachoroidal space in patients with neovascular (wet) age-related macular degeneration (nAMD), and preliminarily evaluate the efficacy of KH658 ophthalmic injection in the treatment of nAMD.
Phase II (efficacy exploration)
Based on the results of phase I tolerability, safety and preliminary efficacy evaluation, two doses of KH658 ophthalmic injection were selected, and intravitreal injection of aflibercept was used as a positive control to evaluate the efficacy and safety of KH658 ophthalmic injection in patients with nAMD.
100 Clinical Results associated with KH658
100 Translational Medicine associated with KH658
100 Patents (Medical) associated with KH658
100 Deals associated with KH658