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NCT05986864PHASE1, PHASE2Recruiting

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

Skyline Therapeutics (US) Inc.

Start Date

2/23/2024

Completion Date

1/30/2026

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

Age Range: 50 years to No maximum

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.

Interventions

GENETIC

SKG0106

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Conditions

Neovascular Age-related Macular Degeneration

Locations

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida 33711

United States

Ophthalmic Consultants of Boston

Boston, Massachusetts 02114

United States

Retina Consultants of Texas

Katy, Texas 77494

United States

Wagner Kapoor Research Institute

Norfolk, Virginia 23502

United States

The Second Hospital Of Anhui Medical University

Hefei, Anhui

China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang

China

Eye Hospital, WMU (Zhejiang Eye Hospital)

Wenzhou, Zhejiang

China

Beijing Hospital

Beijing,

China

Peking Union Medical College Hospital

Beijing,

China