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

Age-related Macular Degeneration Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458595
• Other study ID #: KH658-40101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2024
• Est. completion date: December 28, 2026

Study information

• Verified date: June 2024
• Source: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
• Contact: Ting Hu
• Phone: +8613880999215
• Email: huting[@]cnkh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 28, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Are willing and able to sign the informed consent form (ICF);

2. Female and male aged 50 to 85 years (inclusive) with nAMD;

3. 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;

4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;

5. Have a ETDRS BCVA letter score of =19 in the fellow eye at Screening;

6. Females must be at least 1 year postmenopausal.

Exclusion Criteria:

1. 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.);

2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;

3. 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;

4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;

5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;

6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• KH658
KH658 Ophthalmic Injection

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Origen Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and safety of KH658 in different dose levels		Week 4, Week 26
Primary	Change in BCVA letter		Week 26
Secondary	Incidence of adverse events and adverse reactions		Week 4, 26, 38, 54
Secondary	Efficacy (BCVA, CRT)		Week 38, 54
Secondary	Number of supplemental injections		Week 54
Secondary	Annualized rate of supplemental injections		Week 54
Secondary	Percentage of subjects free of rescue IVT therapy		Week 54