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Clinical Trials in the USA / NCT05986864
Recruiting Phase 1/2

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

NCT05986864 · tracked via the Priya Life Science USA tracker
Sponsor
Skyline Therapeutics (US) Inc.
Phase
Phase 1/2
Started
2024-02-23
Last updated
2026-08-28

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

SKG0106

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

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
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: 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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Retina Vitreous Associates of Florida - Saint Petersburg St. Petersburg Florida Not Yet Recruiting
Ophthalmic Consultants of Boston Boston Massachusetts Recruiting
Retina Consultants of Texas Katy Texas Recruiting
Wagner Kapoor Research Institute Norfolk Virginia Recruiting
The Second Hospital Of Anhui Medical University Hefei Anhui Recruiting
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting
Eye Hospital, WMU (Zhejiang Eye Hospital) Wenzhou Zhejiang Recruiting
Beijing Hospital Beijing China Recruiting
Peking Union Medical College Hospital Beijing China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05986864 on ClinicalTrials.gov ↗ ← All trials in the USA