RecruitingPhase 1Phase 2NCT06458595
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
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).
Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Enrollment
44 participants
Start Date
Jun 28, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 50 YearsMax Age: 85 Years
Inclusion Criteria6
- 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 Criteria6
- 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.
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Interventions
DRUGKH658
KH658 Ophthalmic Injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06458595
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