A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD

Skyline Therapeutics

Status: Enrolling

Conditions: Neovascular (Wet) Age-related Macular Degeneration

Treatments: Genetic: SKG0106

Study type: Observational

Funder types: Industry

Identifiers

NCT06346600

SKG0106-LF

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

83 participants in 3 patient groups

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

Description:

No investigational product will be administered in this study.

Treatment:

Genetic: SKG0106

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

Description:

No investigational product will be administered in this study.

Treatment:

Genetic: SKG0106

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

Description:

No investigational product will be administered in this study.

Treatment:

Genetic: SKG0106