Actively Recruiting
A Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD)
Led by Skyline Therapeutics · Updated on 2024-04-04
83
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe patients with neovascular (wet) age-related macular degeneration (nAMD) who have previously been treated with SKG0106. The study is prospective, non-interventional, and multicenter, focusing on long-term follow-up to evaluate the safety and effects of SKG0106 over a period of up to 5 years after the initial treatment. It includes participants who completed earlier clinical studies involving this treatment. No new study drug or intervention will be administered during this follow-up. Instead, participants will be monitored for safety and efficacy outcomes related to their prior SKG0106 injections at different dose levels. The study groups correspond to participants exposed to three different SKG0106 dose levels, but all receive observational follow-up without additional treatment. Participants will undergo regular assessments to monitor ocular and systemic adverse events, including serious and special interest events, over the 5-year period. Evaluations will also include changes in best corrected visual acuity, macular central subfield thickness, and patient-reported visual function scores. This long-term monitoring aims to provide comprehensive safety and effectiveness data while participants continue their usual care.
CONDITIONS
Brief Title
A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have neovascular (wet) age-related macular degeneration and previously received SKG0106 injection in related studies.
- Participants must voluntarily sign an informed consent form.
- Participants must agree to comply with the study protocol to complete the study.
You will not qualify if you...
- Participants judged by the investigator to be unsuitable for this study.
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 - Up to 5 years post SKG0106 injection
Participants who previously received SKG0106 injections are observed for safety and efficacy outcomes over an extended period.
Trial Site Locations
Total: 10 locations
1
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
2
Retina Consultants of Texas
Katy, Texas, United States, 77494
Not Yet Recruiting
3
Wagner Macula & Retina Center
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
4
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
5
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
6
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Not Yet Recruiting
7
Beijing Hospital
Beijing, China
Not Yet Recruiting
8
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
9
EYE & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
10
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, China
Not Yet Recruiting
Research Team
Y
Yongqin Wang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here