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Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
RecruitingPhase 1/2
Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Who can join
Ages 50 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- SKG0106 (genetic)
Sponsor: Skyline Therapeutics (US) Inc. · Participants: 68 · Started: Feb 23, 2024
Contact the study team
- Eddy Anglade, MD · Phone: +1-908-884-1246
Official record on ClinicalTrials.gov — NCT05986864
Locations in the U.S.
| Florida | Retina Vitreous Associates of Florida - Saint Petersburg, St. Petersburg (Not yet recruiting) |
| Massachusetts | Ophthalmic Consultants of Boston, Boston |
| Texas | Retina Consultants of Texas, Katy |
| Virginia | Wagner Kapoor Research Institute, Norfolk |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.