Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Recruiting now · Phase 1/Phase 2
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT05986864
- Run by
- Skyline Therapeutics (US) Inc.
- People needed
- 68
- Starts
- 2024-02-23
- Expected to finish
- 2026-01-30
- Last updated by the study team
- 2025-01-09
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Peking Union Medical College Hospital — Beijing, China (enrolling)
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (enrolling)
- Retina Consultants of Texas — Katy, Texas, United States (enrolling)
- Wagner Kapoor Research Institute — Norfolk, Virginia, United States (enrolling)
- The Second Hospital Of Anhui Medical University — Hefei, Anhui, China (enrolling)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
- Eye Hospital, WMU (Zhejiang Eye Hospital) — Wenzhou, Zhejiang, China (enrolling)
- Beijing Hospital — Beijing, China (enrolling)
- Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States
Full record on ClinicalTrials.gov
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