Tests KH658 gene therapy in adults with wet age-related macular degeneration
Tests a one-time gene therapy injection in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Source: NCT06458595, who can take part
Where in China
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chengdu Origen Biotechnology Co., Ltd.
- Trial code
- NCT06458595
- Record updated
- 29 November 2024
- Original description
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.Read full original descriptionShow less
A Phase I/II Study to Evaluate the Tolerability, Safety and Efficacy of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD).
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.
Inclusion: 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.
Exclusion: Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination; 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; Have a history of or presence of retinal detachment or choroidal detachment in the study eye.