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

Официальное название

A Multicenter, Dose-escalation and Dose-expansion, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration

Обзор

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

Вмешательства

• Препарат SCT520FF
  SCT520FF dose level 1，IVI
• Препарат SCT520FF
  SCT520FF dose level 2，IVI
• Препарат SCT520FF
  SCT520FF dose level 3，IVI
• Препарат EYLEA 2 MG
  EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period

Первичные конечные точки

• Treatment emergent adverse events(TEAE) [Срок оценки: From Day 0 up to 196days]
• Treatment-related treatment emergent adverse events(TRAE) [Срок оценки: From Day 0 up to 196days]
• Serious adverse event(SAE) [Срок оценки: From Day 0 up to 196days]
• Adverse event of special interest(AESI) [Срок оценки: From Day 0 up to 196days]
• Dose limited toxicity(DLT) [Срок оценки: From Day 0 up to 196days]

Вторичные конечные точки (7)

• Best corrected visual acuity(BCVA) [Срок оценки: Day 0 up to 196 days]
• central retina thickness(CRT) [Срок оценки: Day 0 up to 196days]
• PK profile [Срок оценки: Day 0 up to 196days]
• Cmax [Срок оценки: Day 0 up to 196days]
• Tmax [Срок оценки: Day 0 up to 196days]
• PD profile [Срок оценки: Day 0 up to 196 days]
• Immunogenicity [Срок оценки: Day 0 up to 196days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• MNV caused by non-nAMD exists in the study eye .
• Active inflammation or infection in either eye before randomization.
• Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
• Abnormal liver and kidney function.
• Poorly-controlled blood pressure before randomization.
• History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
• Evidence of significant uncontrolled concomitant diseases.
• Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
• Pregnant, lactating women who can not take contraceptive measures during the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Eye Hospital — Tianjing

Идентификаторы

NCT: NCT06672536 · SCT520FF-A201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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