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

Neovascular (Wet) Age-related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346600
• Other study ID #: SKG0106-LF
• Status: Recruiting
• Start date: April 2, 2024
• Est. completion date: March 2031

Study information

• Verified date: April 2024
• Source: Skyline Therapeutics
• Contact: Yongqin Wang
• Phone: +86 18616737445
• Email: yongqin.wang[@]skytx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: March 2031
• Est. primary completion date: March 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular (Wet) Age-related Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Hospital Of Anhui Medical University	Hefei	Anhui
China	EYE & ENT Hospital of Fudan University	Shanghai
China	Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine	Shanghai
China	Eye Hospital, WMU (Zhejiang Eye Hospital)	Wenzhou	Zhejiang
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retina Consultants of Texas	Katy	Texas
United States	Wagner Macula & Retina Center	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Skyline Therapeutics

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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