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)

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular (Wet) Age-related Macular Degeneration
• Intervention / Treatment: Genetic: SKG0106

• Study Type: Observational
• Enrollment (Estimated): 83

Contacts and Locations

• Study Contact: Name: Yongqin Wang; Phone Number: +86 18616737445; Email: yongqin.wang@skytx.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
  • Beijing, China
    • Not yet recruiting
    • Beijing Hospital
  • Shanghai, China
    • Recruiting
    • Eye & ENT Hospital of Fudan University
  • Shanghai, China
    • Not yet recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The Second Hospital of Anhui Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Provincial People's Hospital
    • Wenzhou, Zhejiang, China
      • Not yet recruiting
      • Eye Hospital, WMU (Zhejiang Eye Hospital)
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Ophthalmic Consultants of Boston
  • Texas
    • Katy, Texas, United States, 77494
      • Not yet recruiting
      • Retina Consultants of Texas
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Not yet recruiting
      • Wagner Macula & Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1; No investigational product will be administered in this study.	Genetic: SKG0106; Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2; No investigational product will be administered in this study.	Genetic: SKG0106; Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.
Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3; No investigational product will be administered in this study.	Genetic: SKG0106; Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Skyline Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: wAMD; nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: SKG0106-LF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No