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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06346600
Other study ID # SKG0106-LF
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04126317 - Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration Phase 2
Completed NCT06184360 - Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
Completed NCT04847895 - Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
Active, not recruiting NCT05439629 - Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration Phase 3
Recruiting NCT05197270 - 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT05473715 - A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment Phase 4