Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration
Running, not enrolling · Phase 1
Conditions studied: Age-Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT05657301
- Run by
- Chengdu Origen Biotechnology Co., Ltd.
- People needed
- 25
- Starts
- 2023-10-16
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria:
- 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 19 (approximately 20/63 to 20/400 Snellen equivalent) in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 19 (approximately 20/40 to 20/400 Snellen equivalent) for the rest of the subjects each cohort; d. Pseudophakia in the study eye, with ocular media to permit high quality fundus imaging at screening and allow planned vitrectomy and subretinal injection; e. Are willing and able to sign the study written informed consent form (ICF).
You may not qualify if…
- Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF
- Retinal pigment epithelial tears or rips at screening
- Any history or presence of vitreous hemorrhage;
- Have any condition preventing visual acuity improvement;
- 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;
- History of intraocular or periocular surgery in the prior 3 months;
- Prior trabeculectomy or other filtration surgery ;
- Any use of long-acting intraocular steroids, including implants, within six months prior;
Where it is running
- 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
Full record on ClinicalTrials.gov
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