KH658
DrugKH658: AAV vector containing a coding sequence for an anti-VEGF protein
NCT Number: NCT06825858
VAN-2401 is Phase I clinical trial to assess the safety and tolerability of KH658 in subjects with neovascular AMD. KH658 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 ocular injections.
This study is active but is not currently recruiting participants.
Notify Me50 year–85 year
All sexes
Interventional
Phase 1
Kanghong Investigative Site, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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a. Previously received IVT treatment of anti-VEGF for neovascular AMD, with documented response to anti-VEGF therapy during the first 2 weeks of screening b. active macular CNV lesion secondary to AMD evidenced by SD-OCT c. Have a ETDRS BCVA letter score of 63 to 25 in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 25 for the rest of the subjects each cohort; d. Are willing and able to sign the study written informed consent form (ICF).
Exclusion criteria
-
KH658: AAV vector containing a coding sequence for an anti-VEGF protein
Time frame: 52 Weeks
type, severity and incidence of ocular and systemic AEs and SAEs
Time frame: 52 Weeks
Change in Best Corrected Visual Acuity
Time frame: 24Weeks
type, severity and incidence of ocular and systemic AEs and SAEs
Time frame: 24Weeks
Mean Number of Rescue Injections
Time frame: 52Weeks
Mean Number of Rescue Injections
Time frame: 24 Weeks
Change in Best Corrected Visual Acuity
Chengdu Origen Biotechnology Co., Ltd.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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