2025-522231-34-00招募中3 期
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 31
- 主要终点
- Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
研究概览
简要总结
To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant reads, understands, and signs an independent ethics committee (IEC)/institutional review board (IRB) approved informed consent form (ICF) prior to any study-specific procedure. If the participant is unable to read and/or write, an impartial witness should be present during the entire informed consent discussion.
- •Participant is ≥18 years old at the time of signing the ICF.
- •Participant has a diagnosis of type 1 or 2 diabetes mellitus (DM) with glycated hemoglobin (HbA1c) <12% at screening. For the full list of inclusion criteria please refer to protocol
排除标准
- •Participant has one or more of the following current ocular conditions in the study eye: a. Proliferative diabetic retinopathy. b. Pre-retinal fibrosis involving the macula. c. Aphakia or absence of the posterior capsule. For the full list of ocular conditions please refer to protocol.
- •Participant has a history of one or more of the following ocular conditions in the study eye: a. Any intraocular inflammation/infection within 90 days prior to screening. b. Non-infectious uveitis, or idiopathic or autoimmune uveitis. For the full list of ocular conditions please refer to protocol.
- •Participant has a hypersensitivity to immunoglobulin products, or has allergies to any of the components of the study treatments
- •Participant currently suffering from or having a history of (where indicated) one or more of the following systemic conditions: a. Uncontrolled blood pressure b. History of vascular disease such as cerebrovascular accident, myocardial infarction, transient ischemic attack, or thromboembolic reaction including pulmonary embolism within 180 days prior to baseline c. New York Heart Association Functional Classification Class III or IV heart failure, or severe uncontrolled cardiac disease (ie, unstable angina). For the full list of exclusion criteria please refer to protocol
研究组 & 干预措施
Aflibercept
Test
干预措施: Aflibercept (Drug)
Eylea 114.3 mg/ml solution for injection
Comparator
干预措施: Eylea 114.3 mg/ml solution for injection (Drug)
结局指标
主要结局
Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
次要结局
- Change from baseline in BCVA as assessed by ETDRS letter score throughout the study at several pre-defined time points
- Gain of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points
- Loss of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points
- Change from baseline in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT) throughout the study at several pre-defined time points
- Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points
- Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points during the trial
- Incidence of ocular and non-ocular treatment-emergent adverse events, adverse events of special interest, and serious adverse events
- Evaluation of ophthalmic parameters (intraocular pressure [IOP], biomicroscopy, and indirect ophthalmoscopy)
- Evaluation of routine safety parameters
- Incidence and titer of anti-drug antibodies at several pre-defined time points during the study
- Incidence of neutralizing antibodies at several pre-defined time points during the study
- Evaluation of the systemic PK of free and bound aflibercept at several pre-defined time points during the study
研究者
Riken Soni
Scientific
Alvotech Swiss AG
研究点 (31)
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