NCT06458595 Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
| NCT ID | NCT06458595 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chengdu Origen Biotechnology Co., Ltd. |
| Condition | Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2024-06-28 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
Eligibility Criteria
Inclusion Criteria: 1. Are willing and able to sign the informed consent form (ICF); 2. Female and male aged 50 to 85 years (inclusive) with nAMD; 3. Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening; 4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening; 5. Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening; 6. Females must be at least 1 year postmenopausal. Exclusion Criteria: 1. Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.); 2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy; 3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening; 4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye; 5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination; 6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06458595 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06458595 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06458595 currently recruiting?
Yes, NCT06458595 is actively recruiting participants. Contact the research team at 026117@cnkh.com for enrollment information.
Where is the NCT06458595 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06458595 clinical trial?
NCT06458595 is sponsored by Chengdu Origen Biotechnology Co., Ltd.. The trial plans to enroll 44 participants.