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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986864
• Other study ID #: SKG0106-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 25, 2024
• Est. completion date: January 30, 2026

Study information

• Verified date: January 2024
• Source: Skyline Therapeutics
• Contact: Yongqin Wang
• Phone: +86 18616737445
• Email: yongqin.wang[@]skytx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 30, 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Genetic:
• SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Hospital Of Anhui Medical University	Hefei	Anhui
China	Eye Hospital, WMU (Zhejiang Eye Hospital)	Wenzhou	Zhejiang
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retina Consultants of Texas	Katy	Texas
United States	Wagner Kapoor Research Institute	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Skyline Therapeutics (US) Inc.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of dose limiting toxicities (DLTs)		4 Weeks
Primary	Type, severity, and incidence of ocular and systemic adverse events (AEs)		52 Weeks
Secondary	Mean change from baseline in best corrected visual acuity (BCVA) at each visit	BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.	52 Weeks
Secondary	Mean change from baseline in central subfield thickness (CST) at each visit	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).	52 Weeks
Secondary	Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit	Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.	52 Weeks