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

Last updated: January 8, 2025
Sponsor: Skyline Therapeutics (US) Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

SKG0106

Clinical Study ID

NCT05986864
SKG0106-101
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Voluntary and able to sign a dated ICF prior to any study-related procedures andable to complete the study as required by the protocol;

  2. Aged ≥ 50 years at screening; Study Eye:

  3. Diagnosis of nAMD as determined by the PI;

  4. Active CNV lesions secondary to age-related macular degeneration (AMD);

  5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI priorto study treatment.

Exclusion

Exclusion Criteria:

  1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectiousblepharitis, uveitis) in the study eye at baseline;

  2. Retinal pigment epithelial tear in the study eye at screening;

  3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhagewithin 4 weeks prior to baseline;

  4. Any condition that, in the opinion of the investigator, may limit visual acuityimprovement in the study eye;

  5. History of retinal detachment or active retinal detachment in the study eye;

  6. Any prior gene therapy.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: SKG0106
Phase: 1/2
Study Start date:
February 23, 2024
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • The Second Hospital Of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Eye Hospital, WMU (Zhejiang Eye Hospital)

    Wenzhou, Zhejiang
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

  • Retina Vitreous Associates of Florida - Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Wagner Kapoor Research Institute

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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