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

Skyline Therapeutics (US) Inc.9 sites in 2 countries68 target enrollmentFebruary 23, 2024

ConditionsNeovascular Age-related Macular Degeneration

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Skyline Therapeutics (US) Inc.
Enrollment: 68
Locations: 9
Primary Endpoint: Type, severity, and incidence of ocular and systemic adverse events (AEs)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 phase 1 dose escalation study, the phase 2 expansion study will be conducted.

Registry

clinicaltrials.gov

Start Date

February 23, 2024

End Date

January 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Skyline Therapeutics (US) Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

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.

Outcomes

Primary Outcomes

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

Time Frame: 52 Weeks

Characteristics of dose limiting toxicities (DLTs)

Time Frame: 4 Weeks

Secondary Outcomes

Mean change from baseline in best corrected visual acuity (BCVA) at each visit(52 Weeks)
Mean change from baseline in central subfield thickness (CST) at each visit(52 Weeks)
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit(52 Weeks)