Tests SKG0106 injection in eye disease causing vision loss
Tests SKG0106, an eye injection, in adults 50 and older with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Key facts
- Where
- Boston, Katy, Norfolk, and St. Petersburg, United StatesSee the 4 sites
- Phase
- Phase 1/2
Where in United States
- Ophthalmic Consultants of BostonBoston, United StatesTaking people
- Retina Consultants of TexasKaty, United StatesTaking people
- Wagner Kapoor Research InstituteNorfolk, United StatesTaking people
- Retina Vitreous Associates of Florida - Saint PetersburgSt. Petersburg, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Skyline Therapeutics (US) Inc.
- Trial code
- NCT05986864
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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.
Inclusion: 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.
Exclusion: Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; Any prior gene therapy; 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; 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; Retinal pigment epithelial tear in the study eye at screening.