Actively Recruiting
An Open-label Dose-escalation Study to Evaluate Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intravitreal Injection in Chinese Patients With Neovascular Age-related Macular Degeneration
Led by Youxin Chen · Updated on 2025-01-08
12
Participants Needed
3
Research Sites
N/A
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 people with neovascular age-related macular degeneration (nAMD). This study is an open-label, dose-escalation clinical trial aimed at assessing these factors after a single intravitreal injection of SKG0106, a gene therapy product, in Chinese patients aged 50 and older who have this eye condition. Participants receive one of three different dose levels of SKG0106 through a single injection into the eye. The study is non-randomized and open-label, meaning both researchers and participants know which dose is given. The trial focuses on evaluating dose-limiting toxicities within 4 weeks and tracking ocular and systemic adverse events over 48 weeks. During the study, participants will have their vision tested using best corrected visual acuity assessments and their eye structure examined by imaging techniques such as spectral domain optical coherence tomography. Patient-reported outcomes about vision quality will also be collected. These evaluations occur at regular visits up to 48 weeks to monitor safety, visual changes, and quality of life after treatment with SKG0106.
CONDITIONS
Brief 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...
- Voluntary 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 due to age-related macular degeneration
- Must have shown response to anti-VEGF therapy before study treatment as assessed by the investigator
You will not qualify if you...
- Any active infection or inflammation in or around the study eye at baseline
- Retinal pigment epithelial tear in the study eye at screening
- Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks before baseline
- Any condition that may limit visual improvement in the study eye according to the investigator
- History of retinal detachment or active retinal detachment in the study eye
- Any prior gene therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 48 weeks
Participants receive a one-time intraocular injection of SKG0106 at one of three dose levels.
Multiple visits over 48 weeks for safety and efficacy assessments
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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