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.
The VAN-2201 clinical trial is a multicenter, open-label, dose-escalating clinical study. The primary objective of the study will be to establish a safe and tolerable dose range in subjects with neovascular AMD. Five dose cohorts are planned to be included in the study, with approximately five subjects per cohort. Subjects who meet the eligibility criteria (i.e. all the inclusion and no exclusion criteria) will be enrolled to receive KH631. KH631 will be delivered at the dose level according to the cohort via intraocular injection. Subjects will be seen monthly until the primary outcome measurement at 24 weeks and through week 52. The subjects will be continued to followed with regular visits until they complete the 104 week visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
KH631: AAV vector containing a coding sequence for an anti-VEGF protein
Kanghong Investigative Site
Phoenix, Arizona, United States
Kanghong Investigative Site
Lemont, Illinois, United States
Kanghong Investigative Site
Boston, Massachusetts, United States
Kanghong Investigative Site
Reno, Nevada, United States
Kanghong Investigative Site
Cherry Hill, New Jersey, United States
Kanghong Investigative Site
Germantown, Tennessee, United States
Kanghong Investigative Site
Dallas, Texas, United States
Safety (Type, Severity and Incidence of ocular and systemic AEs and SAEs)
type, severity and incidence of ocular and systemic AEs and SAEs
Time frame: 52 Weeks
Best Corrected Visual Acuity
Change in Best Corrected Visual Acuity
Time frame: 52 Weeks
Safety (type, severity and incidence of ocular and systemic AEs and SAEs)
type, severity and incidence of ocular and systemic AEs and SAEs
Time frame: 104 Weeks
Rescue Injections
Mean Number of Rescue Injections
Time frame: 104 Weeks
Best Corrected Visual Acuity
Change in Best Corrected Visual Acuity
Time frame: 104 Weeks
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