NCT06213038

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2023

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

January 9, 2024

Last Update Submit

January 6, 2025

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMDwet AMDwAMDnAMD

Outcome Measures

Primary Outcomes (2)

  • Characteristics of dose limiting toxicities (DLTs)

    4 weeks

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

    48 weeks

Secondary Outcomes (3)

  • 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

Study Arms (3)

Dose Level 1

EXPERIMENTAL

SKG0106 One-Time Intraocular Injection Dose Level 1

Genetic: SKG0106

Dose Level 2

EXPERIMENTAL

SKG0106 One-Time Intraocular Injection Dose Level 2

Genetic: SKG0106

Dose Level 3

EXPERIMENTAL

SKG0106 One-Time Intraocular Injection Dose Level 3

Genetic: SKG0106

Interventions

SKG0106GENETIC

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

Dose Level 1Dose Level 2Dose Level 3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Aged ≥ 50 years at screening;
  • Study Eye:
  • Diagnosis of nAMD as determined by the PI;
  • Active CNV lesions secondary to age-related macular degeneration (AMD);
  • Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment

You may not qualify if:

  • 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;
  • Retinal pigment epithelial tear in the study eye at screening;
  • Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
  • Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
  • History of retinal detachment or active retinal detachment in the study eye;
  • Any prior gene therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

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

RECRUITING

Study Officials

  • Youchen Chen

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youchen Chen

CONTACT

13801025972chenyouxinpumch@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 19, 2024

Study Start

May 5, 2023

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)