A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
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)
1 other identifier
observational
83
2 countries
10
Brief Summary
This is 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). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedStudy Start
First participant enrolled
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
April 4, 2024
April 1, 2024
6.9 years
March 27, 2024
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
5 years post study drug injection
Secondary Outcomes (3)
Mean change in best corrected visual acuity (BCVA) at each visit from baseline
5 years post study drug injection
Mean change in macular central subfield thickness (CST) at each visit from baseline
5 years post study drug injection
Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline
5 years post study drug injection
Study Arms (3)
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1
No investigational product will be administered in this study.
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2
No investigational product will be administered in this study.
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3
No investigational product will be administered in this study.
Interventions
Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.
Eligibility Criteria
It is expected that a total of 83 study subjects from parent study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
You may qualify if:
- Subjects who only meet all of the following criteria are eligible for this study:
- nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;
- Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study
You may not qualify if:
- Subjects who are judged by the investigator unsuitable for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Retina Consultants of Texas
Katy, Texas, 77494, United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23502, United States
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
EYE & ENT Hospital of Fudan University
Shanghai, China
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 4, 2024
Study Start
April 2, 2024
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2031
Last Updated
April 4, 2024
Record last verified: 2024-04