Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

NCT06458595 | Recruiting Phase 1

• 1 other identifier: KH658-40101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Tolerability and safety of KH658 in different dose levels

  Week 4， Week 26

• Change in BCVA letter

  Week 26

Secondary Outcomes (5)

• Incidence of adverse events and adverse reactions

  Week 4， 26， 38， 54

• Efficacy (BCVA, CRT)

  Week 38， 54

• Number of supplemental injections

  Week 54

• Annualized rate of supplemental injections

  Week 54

• Percentage of subjects free of rescue IVT therapy

  Week 54

Study Arms (1)

KH658

EXPERIMENTAL

Drug: KH658

Interventions

KH658 DRUG

KH658 Ophthalmic Injection

KH658

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Origen Biotechnology Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Jiarong Du

CONTACT

+86176 0288 9310; 026117@cnkh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 28, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-06

Locations

CN (1)