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

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.

Conditions

Age-Related Macular Degeneration

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Age-Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Phoenix

Kanghong Investigative Site, Phoenix, Arizona, United States, 85016

Lemont

Kanghong Investigative Site, Lemont, Illinois, United States, 60439

Boston

Kanghong Investigative Site, Boston, Massachusetts, United States, 02114

Reno

Kanghong Investigative Site, Reno, Nevada, United States, 89502

Cherry Hill

Kanghong Investigative Site, Cherry Hill, New Jersey, United States, 08034

Germantown

Kanghong Investigative Site, Germantown, Tennessee, United States, 38138

Dallas

Kanghong Investigative Site, Dallas, Texas, United States, 75231

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria:
  • 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. Retinal pigment epithelial tears or rips at screening
  • 3. Any history or presence of vitreous hemorrhage;
  • 4. Have any condition preventing visual acuity improvement;
  • 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. History of intraocular or periocular surgery in the prior 3 months;
  • 7. Prior trabeculectomy or other filtration surgery ;
  • 8. Any use of long-acting intraocular steroids, including implants, within six months prior;

Ages Eligible for Study

50 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Chengdu Origen Biotechnology Co., Ltd.,

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

Study Record Dates

2027-09