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

NCT ID: NCT05672121

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2026-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KH631 Dose 1

dose1:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

KH631

Intervention Type DRUG

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

KH631 Dose 2

dose2:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

KH631

Intervention Type DRUG

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

KH631 Dose 3

dose3:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

KH631

Intervention Type DRUG

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

KH631 Dose 4

dose4:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

KH631

Intervention Type DRUG

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

KH631 Dose 5

dose5:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

KH631

Intervention Type DRUG

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

Interventions

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KH631

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu Origen Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wenbin Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital Affiliated to Capital Medical University

Locations

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Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiang Zheng

Role: CONTACT

[email protected]
86 13880331037

Shanshan Ji

Role: CONTACT

[email protected]
86 18188058101

Facility Contacts

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Wenbin Wei, PhD

Role: primary

[email protected]
86 13701255115

Other Identifiers

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KH631-40101

Identifier Type: -

Identifier Source: org_study_id