A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SKG0106.
- Who it may be relevant to
- Registry conditions: Neovascular (Wet) Age-related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Genetic SKG0106
Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.
Primary outcome measures
- Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [Time frame: 5 years post study drug injection]
Secondary outcome measures (3)
- Mean change in best corrected visual acuity (BCVA) at each visit from baseline [Time frame: 5 years post study drug injection]
- Mean change in macular central subfield thickness (CST) at each visit from baseline [Time frame: 5 years post study drug injection]
- Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline [Time frame: 5 years post study drug injection]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- Subjects who are judged by the investigator unsuitable for this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 7 centers
- The Second Hospital Of Anhui Medical University — Hefei
- Zhejiang Provincial People's Hospital — Hangzhou
- Eye Hospital, WMU (Zhejiang Eye Hospital) — Wenzhou
- Beijing Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
- EYE & ENT Hospital of Fudan University — Shanghai
- Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine — Shanghai
United States · 3 centers
- Ophthalmic Consultants of Boston — Boston
- Retina Consultants of Texas — Katy
- Wagner Macula & Retina Center — Norfolk
Identifiers
NCT: NCT06346600 · SKG0106-LF