Actively Recruiting
Phase I/II Study to Evaluate Safety and Preliminary Effectiveness of SKG0106 Intravitreal Injection for Neovascular Age-related Macular Degeneration
Led by Skyline Therapeutics (US) Inc. · Updated on 2025-01-09
68
Participants Needed
9
Research Sites
101 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 people with neovascular age-related macular degeneration (nAMD). This phase 1/2 study builds upon findings from an earlier phase 1 dose escalation trial and aims to further assess SKG0106, a gene therapy delivered through an injection into the eye. Participants receive SKG0106, which is a gene therapy made from a recombinant adeno-associated virus vector, given as an intravitreal injection directly into the study eye. The study includes a phase 1 dose escalation followed by a phase 2 expansion to collect more data on safety and preliminary efficacy. During the study, researchers monitor participants for dose limiting toxicities over 4 weeks and track the type, severity, and frequency of eye-related and systemic side effects for up to 52 weeks. Participants will have eye examinations and other assessments to evaluate safety and treatment effects throughout the study period.
CONDITIONS
Official Title
Phase I/II Study of SKG0106 Intravitreal Injection 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 and complete study procedures
- Age 50 years or older at screening
- Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye as determined by the investigator
- Active choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration
- Responsive to anti-VEGF therapy before study treatment as assessed by the investigator
You will not qualify if you...
- Active intraocular or periocular infection or inflammation in 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 as judged by the investigator
- History of retinal detachment or active retinal detachment in the study eye
- Previous gene therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States, 33711
Not Yet Recruiting
2
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Retina Consultants of Texas
Katy, Texas, United States, 77494
Actively Recruiting
4
Wagner Kapoor Research Institute
Norfolk, Virginia, United States, 23502
Actively Recruiting
5
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
6
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
7
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Actively Recruiting
8
Beijing Hospital
Beijing, China
Actively Recruiting
9
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yongqin Wang
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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