A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorYouxin Chen

About this trial

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.

Eligibility criteria

Qualifiers

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;

Diagnosis of nAMD as determined by the PI;

Active CNV lesions secondary to age-related macular degeneration (AMD);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SKG0106

Treatment groups

12 Participants
are divided into 3 treatment groups

Locations

3
Peking Union Medical College Hospital Beijing China
Eye & ENT Hospital of Fudan University Shanghai China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China

Sponsors and collaborators

Youxin Chen

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution