Clinical trial

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)

Name

SKG0106-LF

Description

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 arms

Trial start

2024-04-02

Estimated PCD

2031-03-01

Trial end

2031-03-01

Status

Recruiting

Treatment

SKG0106

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

Arms:

Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1, Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2, Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3

Size

Primary endpoint

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 83, 'type': 'ESTIMATED'}}

Updated at

2024-04-04

1 organization

1 product

1 indication

Organization

Skyline Therapeutics

Product

SKG0106

Indication

Age-related Macular Degeneration