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Clinical Trials associated with KH658 / Not yet recruitingPhase 1 A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants with Neovascular Age-related Macular Degeneration
VAN-2401 is Phase I clinical trial to assess the safety and tolerability of KH658 in subjects with neovascular AMD. KH658 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular ocular injections.
/ Not yet recruitingPhase 1/2 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.
A 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- |
100 Clinical Results associated with KH658
100 Translational Medicine associated with KH658
100 Patents (Medical) associated with KH658
100 Deals associated with KH658