Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Last updated: November 26, 2024
Sponsor: Chengdu Origen Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Aging

Macular Degeneration

Geographic Atrophy

Treatment

KH631

Clinical Study ID

NCT05672121
KH631-40101
  • Ages 50-85
  • All Genders

Study Summary

KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Are willing and able to sign the study written informed consent form (ICF); 2. Menand 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-VEGFtherapy(Response is defined as reduction in CRT≥50μm or at least 30% reduction influid 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) forthe 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 3months after intraocular lens implantation) in the study eye; 7.Female subjects musthave been postmenopausal for at least 1 year.

Exclusion

Exclusion Criteria:

  • 1.Any other cause of CNV, including pathologic myopia, etc, or other diseases exceptnAMD 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 ornarrow pupil of the study eye; 3.Active or history of retinal detachment in thestudy eye; 4.Uncontrolled glaucoma or ocular hypertension; 5.Have taken the drugknown to have retinal toxicity; 6.History of intraocular surgery; 7.Uncontrolledhypertension despite medication at the screening visit.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: KH631
Phase: 1/2
Study Start date:
February 06, 2023
Estimated Completion Date:
December 28, 2026

Connect with a study center

  • Beijing Tongren Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

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