ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-16
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05657301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF
  2. 2. Retinal pigment epithelial tears or rips at screening
  3. 3. Any history or presence of vitreous hemorrhage;
  4. 4. Have any condition preventing visual acuity improvement;
  5. 5. Have any other cause of CNV; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, Epiretinal membrane or vitreo-macular traction; full thickness macular hole;
  6. 6. History of intraocular or periocular surgery in the prior 3 months;
  7. 7. Prior trabeculectomy or other filtration surgery ;
  8. 8. Any use of long-acting intraocular steroids, including implants, within six months prior;

Contacts and Locations

Principal Investigator

Avner Ingerman, MD, MSc
STUDY_DIRECTOR
Vanotech Ltd.

Study Locations (Sites)

Kanghong Investigative Site
Phoenix, Arizona, 85016
United States
Kanghong Investigative Site
Lemont, Illinois, 60439
United States
Kanghong Investigative Site
Boston, Massachusetts, 02114
United States
Kanghong Investigative Site
Reno, Nevada, 89502
United States
Kanghong Investigative Site
Cherry Hill, New Jersey, 08034
United States
Kanghong Investigative Site
Germantown, Tennessee, 38138
United States
Kanghong Investigative Site
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Chengdu Origen Biotechnology Co., Ltd.

  • Avner Ingerman, MD, MSc, STUDY_DIRECTOR, Vanotech Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Age-Related Macular Degeneration