Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD

ConditionnAMD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age45-80
SponsorSinocelltech Ltd.

About this trial

Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.

Eligibility criteria

Qualifiers

Signed informed consent form.

Age≥45 years, ≤80 years,male or femal.

The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.

Disqualifiers

Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.

Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.

Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.

The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.

Trial design

Treatments tested in this trial

  • SCT520FF
  • SCT520FF
  • SCT520FF
  • EYLEA 2 MG

Treatment groups

82 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Sinocelltech Ltd.

Lead sponsor

Tianjin Medical University Eye Hospital

Collaborator