Gene therapy for age-related vision loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of KH631, a gene therapy using an adeno-associated virus vector, administered via subretinal injection for patients with neovascular age-related macular degeneration (nAMD). The study aims to provide a long-term, stable therapeutic protein after a single injection, potentially reducing the treatment burden associated with ongoing anti-VEGF therapies. Participants must be aged 50 to 85 and currently receiving anti-VEGF treatment, with specific visual acuity and response criteria. The trial is conducted in a phased approach to assess both initial safety and longer-term effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.Are willing and able to sign the study written informed consent form (ICF); 2. Men and women ≥ 50 and ≤85 years of age, diagnosed with nAMD at the Screening visit; 3. Subjects must be under active anti-VEGF treatment for nAMD and received a minimum of 3 injections within 6 months prior to screening; 4. Response to anti-VEGF therapy(Response is defined as reduction in CRT≥50μm or at least 30% reduction in fluid by OCT compared to disease at the worst); 5. BCVA between ≤20/63 and ≥20/400(≤63 and ≥19 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters) for the first patient in each cohort followed by BCVA between ≤20/40 and ≥20/400(≤73 and ≥19 ETDRS letters) for the rest of the cohort; 6. Must be pseudophakic(at least 3 months after intraocular lens implantation) in the study eye; 7.Female subjects must have been postmenopausal for at least 1 year.

Exclusion Criteria:

* 1.Any other cause of CNV, including pathologic myopia, etc, or other diseases except nAMD have an influence on the test of macular or affect the central visual acuity; 2.Presence of an implant, refractive media opacity affects fundus examination or narrow pupil of the study eye; 3.Active or history of retinal detachment in the study eye; 4.Uncontrolled glaucoma or ocular hypertension; 5.Have taken the drug known to have retinal toxicity; 6.History of intraocular surgery; 7.Uncontrolled hypertension despite medication at the screening visit.

Where it's running

• Beijing Tongren Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Wenbin Wei, PhD — Beijing Tongren Hospital Affiliated to Capital Medical University
• Study coordinator: Qiang Zheng
• Email: zhengqiang@cnkh.com
• Phone: 86 13880331037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.