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

ConditionNeovascular Age-related Macular Degeneration

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

Sponsors and collaborators

Youxin Chen

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov