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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05986864
Other study ID # SKG0106-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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