Actively Recruiting
Study of SKG0106 Gene Therapy by Single Eye Injection for Neovascular Age-related Macular Degeneration Open-label Dose-escalation Trial Assessing Safety, Early Effects, and Immune Response
Led by Youxin Chen · Updated on 2025-01-08
12
Participants Needed
3
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, early effectiveness, immune response, and how the body processes SKG0106 in patients with neovascular age-related macular degeneration (nAMD). This Phase 1 study focuses on people aged 50 and older who have active choroidal neovascularization (CNV) related to AMD and who have previously responded to anti-VEGF treatments. The study involves a single intravitreal injection of SKG0106, a gene therapy product based on a recombinant adeno-associated virus (AAV) vector. This open-label trial includes dose escalation to assess safety and immune response after the injection, with close monitoring for adverse events and drug behavior in the body. Participants will be monitored for up to 48 weeks to evaluate dose-limiting toxicities during the first 4 weeks and to track any ocular or systemic adverse events throughout the study. Researchers will assess eye health, immune reactions, and treatment effects using clinical exams and safety tests to understand SKG0106's impact and tolerability in this patient group.
CONDITIONS
Official Title
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree and able to sign informed consent before any study procedures
- Aged 50 years or older at screening
- Diagnosed with neovascular age-related macular degeneration as determined by the investigator
- Have active choroidal neovascularization lesions secondary to AMD
- Have shown response to anti-VEGF therapy prior to study treatment
You will not qualify if you...
- Have any active intraocular or periocular infection or inflammation in the study eye at baseline
- Have retinal pigment epithelial tear in the study eye at screening
- Have current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks before baseline
- Have any condition that might limit visual acuity improvement in the study eye
- Have a history of or current retinal detachment in the study eye
- Have received any prior gene therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
2
Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
3
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
Actively Recruiting
Research Team
Y
Youchen Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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