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NCT Number: NCT06346600

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

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Key information

Conditions

Neovascular (Wet) Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital Of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SKG0106

Genetic

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

Primary outcomes

  1. 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

  1. Mean change in best corrected visual acuity (BCVA) at each visit from baseline

    Time frame: 5 years post study drug injection

    BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at each visit.

  2. Mean change in macular central subfield thickness (CST) at each visit from baseline

    Time frame: 5 years post study drug injection

    Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit.

  3. Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline

    Time frame: 5 years post study drug injection

    Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongqin Wang

CONTACT

[email protected]

+86 18616737445

Sponsors and collaborators

Lead sponsor

Skyline Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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