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A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Phase 1
Recruiting
Conditions
Neovascular Age-related Macular Degeneration
Interventions
Genetic: SKG0106
Registration Number
NCT06213038
Lead Sponsor
Youxin Chen
Brief Summary

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
12
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Dose Level 3SKG0106SKG0106 One-Time Intraocular Injection Dose Level 3
Dose Level 1SKG0106SKG0106 One-Time Intraocular Injection Dose Level 1
Dose Level 2SKG0106SKG0106 One-Time Intraocular Injection Dose Level 2
Primary Outcome Measures
NameTimeMethod
Characteristics of dose limiting toxicities (DLTs)4 weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)48 weeks
Secondary Outcome Measures
NameTimeMethod
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.24 weeks
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).24 weeks
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.48 weeks

Trial Locations

Locations (3)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

🇨🇳

Shanghai, China

Peking Union Medical College Hospital

🇨🇳

Beijing, China

Eye & ENT Hospital of Fudan University

🇨🇳

Shanghai, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
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