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Status:

RECRUITING

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

Lead Sponsor:

Skyline Therapeutics (US) Inc.

Conditions:

Neovascular Age-related Macular Degeneration

Eligibility:

All Genders

50+ years

Phase:

PHASE1

PHASE2

Brief 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 ph...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    February 23 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 30 2026

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT05986864

    Start Date

    February 23 2024

    End Date

    January 30 2026

    Last Update

    January 9 2025

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, United States, 33711

    2

    Ophthalmic Consultants of Boston

    Boston, Massachusetts, United States, 02114

    3

    Retina Consultants of Texas

    Katy, Texas, United States, 77494

    4

    Wagner Kapoor Research Institute

    Norfolk, Virginia, United States, 23502