NCT07614776招募中3 期
A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 304
- 试验地点
- 64
研究概览
简要总结
The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men or women ≥ 50 years old, capable of giving signed informed consent
- •Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
- •Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
- •The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
- •Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
排除标准
- •Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:
- •Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
- •Scar, fibrosis, or atrophy involving the central subfield in the study eye
- •Scar or fibrosis involving > 50% of the total lesion in the study eye
- •Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
- •History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
- •Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
- •Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye
- •History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
- •Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization
- •Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
- •Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
- •History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation
- •Other protocol-specified exclusion criteria
研究组 & 干预措施
Aflibercept (US) 8 mg
Active Comparator
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
干预措施: Aflibercept (US) 8 mg (Drug)
ABP 938 8 mg
Experimental
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
干预措施: ABP 938 8 mg (Drug)
研究者
研究点 (64)
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