A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association
- Glycated hemoglobin (HbA1c) <= 12%
- For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) >= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters
排除标准
- Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Uncontrolled blood pressure
- For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.
- For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant
- History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
- Active intraocular inflammation in either eye
- Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye
研究组 & 干预措施
Part 3: MAD (RO7823653 + Faricimab)
Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.
干预措施: RO7823653 (Drug)
Part 1: Multiple Ascending Dose (MAD) Monotherapy
Participants will receive multiple doses of RO7823653, administered as an IVT injection.
干预措施: RO7823653 (Drug)
Part 2: Optional Multiple-Dose Expansion
Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage.
干预措施: RO7823653 (Drug)
Part 3: MAD (RO7823653 + Faricimab)
Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.
干预措施: Faricimab (Drug)
结局指标
主要结局
Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
时间窗: Up to approximately 20 Weeks
次要结局
- Serum Concentrations of RO7823653(Up to approximately 20 Weeks)
- Aqueous Humor Concentrations of RO7823653(Up to approximately 20 Weeks)
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653(Up to approximately 20 Weeks)
- Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score(Up to approximately 20 Weeks)
- Change From Baseline in Retinal Thickness(Up to approximately 20 Weeks)
- Recommended Dose of RO7823653(Up to approximately 20 Weeks)
研究者
研究点 (12)
标识符
- NCT 编号
- NCT07425522
- 其他研究编号
- GR46431
日期
- 首次提交
- (7个月前)
- 首次发布
- (7个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (19天前)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否