NCT05986864

Brief 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.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2024

Typical duration for phase_1

Geographic Reach
2 countries

9 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

August 3, 2023

Last Update Submit

January 8, 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)

    52 Weeks

Secondary Outcomes (3)

  • Mean change from baseline in best corrected visual acuity (BCVA) at each visit

    52 Weeks

  • Mean change from baseline in central subfield thickness (CST) at each visit

    52 Weeks

  • Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit

    52 Weeks

Study Arms (3)

Phase I: Low dose

EXPERIMENTAL

SKG0106 One-Time Intraocular Injection Dose Level 1

Genetic: SKG0106

Phase I: Medium dose

EXPERIMENTAL

SKG0106 One-Time Intraocular Injection Dose Level 2

Genetic: SKG0106

Phase I: High dose

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

Phase I: High dosePhase I: Low dosePhase I: Medium dose

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 (9)

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, 33711, United States

NOT YET RECRUITING

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

RECRUITING

Retina Consultants of Texas

Katy, Texas, 77494, United States

RECRUITING

Wagner Kapoor Research Institute

Norfolk, Virginia, 23502, United States

RECRUITING

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Eye Hospital, WMU (Zhejiang Eye Hospital)

Wenzhou, Zhejiang, China

RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Central Study Contacts

Yongqin Wang

CONTACT

+86 18616737445yongqin.wang@skytx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

February 23, 2024

Primary Completion

January 1, 2026

Study Completion

January 30, 2026

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)CN(5)