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

Skyline Therapeutics83 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Neovascular (Wet) Age-related Macular Degeneration

Interventions

SKG0106GENETIC

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

NOT_YET_RECRUITING

Retina Consultants of Texas

Katy, Texas, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Time frame: 5 years post study drug injection

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 5 years post study drug injection

Central Contacts

Yongqin Wang

CONTACT

+86 18616737445 yongqin.wang@skytx.com

Data from ClinicalTrials.gov

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