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A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration

NCT06213038•Youxin Chen

View on ClinicalTrials.gov

Summary

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
•2. Aged ≥ 50 years at screening;
•Study Eye:
•3. Diagnosis of nAMD as determined by the PI;
•4. Active CNV lesions secondary to age-related macular degeneration (AMD);
•5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment

Exclusion Criteria

•1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
•2. Retinal pigment epithelial tear in the study eye at screening;
•3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
•4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
•5. History of retinal detachment or active retinal detachment in the study eye;
•6. Any prior gene therapy.

Locations (3)

Peking Union Medical College Hospital

Beijing, China

Eye & ENT Hospital of Fudan University

Shanghai, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Key Dates

Start Date

May 5, 2023

Primary Completion Date

May 30, 2025

Completion Date

May 30, 2025

Last Updated

January 8, 2025

Enrollment

ESTIMATED participants

Conditions

Neovascular Age-related Macular Degeneration

Interventions

SKG0106

GENETIC

Contacts

Youchen Chen

CONTACT

13801025972 chenyouxinpumch@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Inclusion Criteria

Exclusion Criteria

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