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CompletedNCT06213038Updated Sep 11, 2026

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

A Phase 1 interventional study of SKG0106 in Neovascular Age-related Macular Degeneration, sponsored by Youxin Chen. Completed at 3 sites in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Youxin Chen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2023, registered Jan 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Neovascular Age-related Macular Degeneration

Keywords

  • AMD
  • wet AMD
  • wAMD
  • nAMD
03

In context

Lead sponsor

This is the only study on the registry with Youxin Chen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Dose Level 1

    SKG0106 One-Time Intraocular Injection Dose Level 1

    Genetic: SKG0106

  • Experimental
    Dose Level 2

    SKG0106 One-Time Intraocular Injection Dose Level 2

    Genetic: SKG0106

  • Experimental
    Dose Level 3

    SKG0106 One-Time Intraocular Injection Dose Level 3

    Genetic: SKG0106

Interventions

  • GeneticSKG0106

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

06

What researchers measure

Primary outcomes

  1. Characteristics of dose limiting toxicities (DLTs)

    Time frame: 4 weeks

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

    Time frame: 48 weeks

Secondary outcomes

  1. 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.

    Time frame: 24 weeks

  2. 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).

    Time frame: 24 weeks

  3. 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.

    Time frame: 48 weeks

07

Study locations

3 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06213038
Lead sponsor
Youxin Chen
Responsible party
Youxin Chen (Professor, Peking Union Medical College Hospital) — Sponsor-investigator
First posted
Jan 19, 2024
Start date
May 5, 2023
Primary completion
Nov 21, 2025
Completion
Nov 21, 2025
Last update
Sep 11, 2026

Study contacts

Youchen Chen
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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