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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06346600

Enrollment

Registered

2024-04-04

Start date

2025-04-02

Completion date

2031-03-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular (Wet) Age-related Macular Degeneration

Keywords

nAMD, wAMD

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.

Interventions

GENETICSKG0106

Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
Mean change in best corrected visual acuity (BCVA) at each visit from baseline	5 years post study drug injection	BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at each visit.
Mean change in macular central subfield thickness (CST) at each visit from baseline	5 years post study drug injection	Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit.
Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline	5 years post study drug injection	Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.

Countries

China, United States

Contacts

CONTACTEddy Anglade, MD

eanglade@focusbiosciences.com+1-908-884-1246

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026