NCT04656561已完成2 期
A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Masked, 4-Arm, Sham-Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) - The ARCHER Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 53
- 主要终点
- GA lesion growth rate
研究概览
简要总结
This study is being conducted in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) to determine if intravitreal (IVT) injections of ANX007 reduce GA lesion growth rate. The results will be used to guide further development of ANX007 in participants with geographic atrophy. The total duration of participation is expected to be approximately 19 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration as determined by the Investigator and confirmed by the Central Reading Center.
- •GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening:
- •Well-demarcated GA with a total area (baseline lesion size) ≥2.5 millimeter squared (mm^2) and ≤17.5 mm^
- •If GA is multifocal, at least 1 focal lesion must measure ≥1.25 mm^2 with the overall aggregate area of GA as specified above.
- •Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (that is, pattern = none) is exclusionary.
- •The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.
- •Normal luminance BCVA of 24 to 83 letters, inclusive, using ETDRS charts (20/25 to 20/320 Snellen equivalent, inclusive).
- •A female participant is eligible if she is not pregnant or breastfeeding and is a woman of non-childbearing potential or is using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 30 days after the last dose of study intervention.
排除标准
- •Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.
- •Any evidence of choroidal neovascularization (CNV) in the study eye:
- •Any history of CNV of any cause based on medical history.
- •Evidence of prior or active CNV or related findings (for example, retinal pigment epithelial rips or tears) based on FAF, Spectral Domain Optical Coherence Tomography (SD-OCT) imaging, intravenous fluorescein angiography (IVFA) and color fundus photo as assessed by the Central Reading Center.
- •Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.
- •Uncontrolled glaucoma in the study eye (Intraocular pressure [IOP] >25 mmHg despite treatment with anti- glaucoma medication) or history of neovascular glaucoma.
- •History of glaucoma filtration surgery, minimally-invasive glaucoma surgery involving an implant, or vitrectomy surgery, or other procedure in the study eye that could affect drug distribution and/or clearance.
- •Any current or prior ocular disease, other than geographic atrophy, that in the opinion of the Investigator could interfere with the conduct of the study including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye.
- •History of any prior IVT treatment for any indication in the study eye.
- •Any prior treatment for AMD in the study eye (for example, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals.
研究组 & 干预措施
ANX007 Group 1
Experimental
ANX007 administered every month
干预措施: ANX007 (Drug)
ANX007 Group 2
Experimental
ANX007 administered every other month
干预措施: ANX007 (Drug)
Sham Group 3
Sham Comparator
Sham injection administered every month
干预措施: Sham comparator (Other)
Sham Group 4
Sham Comparator
Sham injection administered every other month
干预措施: Sham comparator (Other)
结局指标
主要结局
GA lesion growth rate
时间窗: Baseline to Month 12
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
次要结局
- Low-luminance visual acuity deficit (LL-VD)(Baseline to Month 18)
- Safety: Participants with treatment-emergent adverse events (TEAEs)(Baseline to Month 18)
- Best corrected visual acuity (BCVA)(Baseline to Month 18)
- Low-luminance BCVA (LL-BCVA)(Baseline to Month 18)
研究者
研究点 (53)
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