A Multicenter, Open-Labeled, Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of Intravitreal AG-73305 in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate the safety and efficacy of 4 dose cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).
The objectives of this study were to evaluate the safety, tolerability, duration of effect, systemic pharmacokinetic and immunogenicity profiles of ascending doses of AG-73305 administered by intravitreal injection to patients with DME. Pharmacodynamic endpoints (e.g., best-corrected visual acuity [BCVA], spectral domain optical coherence tomography [SD-OCT], and optical coherence tomography angiography [OCT-A]) were evaluated over 6 months post-treatment. The maximum tolerated dose or the highest administered dose was evaluated for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older at the screening visit
- •Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
- •Presence of center-involving DME in the study eye with CST ≥ 325 μm
- •Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients
- •Cohort 1: Previously treated with an anti-VEGF in the study eye; Cohorts 2, 3, and 4: Previously treated or treatment-naïve to the study eye
排除标准
- •Uncontrolled diabetes mellitus, defined as hemoglobin A1c > 12.0% at Screening
- •Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline
- •Chronic renal disease
- •Any active infection in either eye
- •Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline
- •Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye
- •Uncontrolled intraocular pressure (IOP), defined as an IOP > 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with > 2 topical hypotensive medications
- •Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye
研究组 & 干预措施
Cohort 1
0.5 mg AG-73305 solution, single injection.
干预措施: AG-73305 (Biological)
Cohort 2
1 mg AG-73305 solution, single injection.
干预措施: AG-73305 (Biological)
Cohort 3
2 mg AG-73305 solution, single injection.
干预措施: AG-73305 (Biological)
Cohort 4
4 mg AG-73305 solution, single injection.
干预措施: AG-73305 (Biological)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: 1 month after dosing
BCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.
次要结局
- Mean Change From Baseline in Central Subfield Thickness (CST)(1 month after dosing)