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

NCT05657301 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-31

No results posted yet for this study

Summary

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.

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

KH631

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

Sponsors & Collaborators

  • Chengdu Origen Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Avner Ingerman, MD, MSc · Vanotech Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657301 on ClinicalTrials.gov