Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KH658.
- Who it may be relevant to
- Registry conditions: Age-related Macular Degeneration. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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.
Interventions
- Drug KH658
KH658 Ophthalmic Injection
Primary outcome measures
- Tolerability and safety of KH658 in different dose levels [Time frame: Week 4， Week 26]
- Change in BCVA letter [Time frame: Week 26]
Secondary outcome measures (5)
- Incidence of adverse events and adverse reactions [Time frame: Week 4， 26， 38， 54]
- Efficacy (BCVA, CRT) [Time frame: Week 38， 54]
- Number of supplemental injections [Time frame: Week 54]
- Annualized rate of supplemental injections [Time frame: Week 54]
- Percentage of subjects free of rescue IVT therapy [Time frame: Week 54]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT06458595 · KH658-40101