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NCT Number: NCT05986864

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

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

  • Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
  • Aged ≥ 50 years at screening;

Study Eye:

  • Diagnosis of nAMD as determined by the PI;
  • Active CNV lesions secondary to age-related macular degeneration (AMD);
  • Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.

Exclusion criteria

  • Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
  • Retinal pigment epithelial tear in the study eye at screening;
  • Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
  • Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
  • History of retinal detachment or active retinal detachment in the study eye;
  • Any prior gene therapy.

Treatment and study plan

SKG0106

Genetic

SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Primary outcomes

  1. Characteristics of dose limiting toxicities (DLTs)

    Time frame: 4 Weeks

  2. Type, severity, and incidence of ocular and systemic adverse events (AEs)

    Time frame: 52 Weeks

Secondary outcomes

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

    Time frame: 52 Weeks

    BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.

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

    Time frame: 52 Weeks

    Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available).

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

    Time frame: 52 Weeks

    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 (US) Inc.

Industry

Registry information

Official study title

Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jan 9, 2025

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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