Clinical trial NCT06346600: A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular (Wet) Age-related Macular Degeneration
Keywords: nAMD
wAMD
Lead sponsor: Skyline Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 83
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.


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

Primary outcomes:
measure: Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
timeFrame: 5 years post study drug injection
Secondary outcomes:
measure: Mean change in best corrected visual acuity (BCVA) at each visit from baseline
timeFrame: 5 years post study drug injection
measure: Mean change in macular central subfield thickness (CST) at each visit from baseline
timeFrame: 5 years post study drug injection
measure: Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline
timeFrame: 5 years post study drug injection
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
state: Anhui
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital, WMU (Zhejiang Eye Hospital)
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: EYE & ENT Hospital of Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Study officials:
References: