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

Phase 1

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Genetic: SKG0106

• Registration Number: NCT05986864
• Lead Sponsor: Skyline Therapeutics (US) Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2024-02-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-01
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I: High dose	SKG0106	SKG0106 One-Time Intraocular Injection Dose Level 3
Phase I: Medium dose	SKG0106	SKG0106 One-Time Intraocular Injection Dose Level 2
Phase I: Low dose	SKG0106	SKG0106 One-Time Intraocular Injection Dose Level 1

Primary Outcome Measures

Name	Time	Method
Type, severity, and incidence of ocular and systemic adverse events (AEs)	52 Weeks
Characteristics of dose limiting toxicities (DLTs)	4 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in best corrected visual acuity (BCVA) at each visit	52 Weeks	BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.
Mean change from baseline in central subfield thickness (CST) at each visit	52 Weeks	Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available).
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit	52 Weeks	Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.

Trial Locations

Locations (9)

Retina Vitreous Associates of Florida - Saint Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Retina Consultants of Texas; 🇺🇸 Katy, Texas, United States

Wagner Kapoor Research Institute; 🇺🇸 Norfolk, Virginia, 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