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

Recruiting
50 years of age
Both
Phase 1/2

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Overview

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

Inclusion criteria:

  1. 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;
  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 prior to study treatment.

Exclusion Criteria:

  1. 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;
  2. Retinal pigment epithelial tear in the study eye at screening;
  3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
  4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
  5. History of retinal detachment or active retinal detachment in the study eye;
  6. Any prior gene therapy.

Study details

Neovascular Age-related Macular Degeneration

NCT05986864

Skyline Therapeutics (US) Inc.

19 January 2025

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