NCT05986864PHASE1, PHASE2Recruiting
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Skyline Therapeutics (US) Inc.
Start Date
2/23/2024
Completion Date
1/30/2026
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 Criteria
Age Range: 50 years to No maximum
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.
Interventions
GENETIC
SKG0106
Conditions
Neovascular Age-related Macular Degeneration
Locations
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida 33711
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United States
Retina Consultants of Texas
Katy, Texas 77494
United States
Wagner Kapoor Research Institute
Norfolk, Virginia 23502
United States
The Second Hospital Of Anhui Medical University
Hefei, Anhui
China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
China
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang
China
Beijing Hospital
Beijing,
China
Peking Union Medical College Hospital
Beijing,
China