Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Recruiting now · Phase 1/Phase 2
Conditions studied: Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT06458595
- Run by
- Chengdu Origen Biotechnology Co., Ltd.
- People needed
- 44
- Starts
- 2024-06-28
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2024-11-29
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Are willing and able to sign the informed consent form (ICF);
- Female and male aged 50 to 85 years (inclusive) with nAMD;
- 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;
- Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
- Females must be at least 1 year postmenopausal.
You may not qualify if…
- 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.);
- Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- 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;
- Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
- Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
Where it is running
- Tianjin Medical University General Hospital — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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