๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-25

Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration (NCT05657301)

A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Chengdu Origen Biotechnology Co., Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 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 intraocular injections.

Who can join: Review the eligibility criteria below.

Location: Kanghong Investigative Site โ€” Phoenix, Arizona

Age range: 50 Years to 85 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (7 Sites)

  • Kanghong Investigative Site โ€” Phoenix, Arizona
  • Kanghong Investigative Site โ€” Lemont, Illinois
  • Kanghong Investigative Site โ€” Boston, Massachusetts
  • Kanghong Investigative Site โ€” Reno, Nevada
  • Kanghong Investigative Site โ€” Cherry Hill, New Jersey
  • Kanghong Investigative Site โ€” Germantown, Tennessee
  • Kanghong Investigative Site โ€” Dallas, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—