An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants With Ocular Treatment Emergent Adverse Events
研究概览
简要总结
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
详细描述
Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their routine treatment scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 50 years of age at baseline
- •Patients diagnosed with nAMD (uni- or bilateral)
- •Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase)
- •Willing and able to comply with all study procedures, and be likely to complete the study
- •Signed informed consent must be obtained before any assessment is performed
排除标准
- •Active, suspected or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis
- •Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)
- •History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product
- •Visual acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness
- •Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening
- •Systemic treatment with long-acting corticosteroids (more than 10 mg prednisolone equivalent) within 3 months prior to screening Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
- •Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye any time during the past 3 months
- •Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment
- •Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)
- •Participants who do not comply with the local COVID-19 regulations of the study site
研究组 & 干预措施
SOK583A1
SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
干预措施: SOK583A1 (Drug)
结局指标
主要结局
Number of Participants With Ocular Treatment Emergent Adverse Events
时间窗: 31 days
Number of participants with ocular treatment emergent adverse events were reported.
Number of Participants With Non-ocular Treatment Emergent Adverse Events
时间窗: 31 days
Number of participants with non-ocular treatment emergent adverse events were reported.
次要结局
未报告次要终点