NCT06825858

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Chengdu Origen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	KH658	KH658: AAV vector containing a coding sequence for an anti-VEGF protein

Timeline

• Start date: 2025-04-07
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-02-13
• Last updated: 2026-01-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study