Actively Recruiting
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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
This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
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
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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