A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 20
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in participants with GA secondary to AMD in at least one eye in Part 1, or both eyes in Part 2, after multiple unilateral intravitreal (IVT) doses.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Part 1A of the study will be open-label and non-randomized while Part 1B and 2 will be masked and randomized.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequately clear ocular media, adequate pupillary dilation, and fixation to allow acquisition of good quality fundus imaging
- •GA that resides completely within the fundus autofluorescence (FAF) imaging field
- •Presence of hyperautofluorescence of either banded or diffuse pattern adjacent to the GA area on FAF
- •Study eye has early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) score as follows:
- •Part 1A: 19 to 48 letters, inclusively
- •Part 1B: > 19 letters
- •Part 2: ≥ 24 letters
- •Total GA lesion size must be as follows:
- •Parts 1A and 1B: ≥ 1.25 square millimeter (mm^2) and ≤ 20 mm^2 )
- •Part 2: ≥ 2.5 mm^2 and ≤ 20 mm^2
排除标准
- •Ocular Exclusion Criteria for the Study Eye:
- •Aphakic or pseudophakic with intraocular lens outside of the capsular bag
- •Previous laser photocoagulation or IVT anti-vascular endothelial growth factor (VEGF) for CNV, diabetic macular edema (DME), retinal vein occlusion (RVO), or proliferative diabetic retinopathy
- •Active or history of CNV
- •Ocular Exclusion Criteria for the Non-Study Eye:
- •- Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
- •Ocular Exclusion Criteria for Both Eyes:
- •Macular atrophy in either eye due to causes other than AMD
- •Part 2: Evidence of prior or active CNV
- •Prior treatment with any approved therapy for GA (Syfovre, Izervay) in either eye for Part 1A and Part 2 ≤ 20 weeks prior to Day
- •For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1
研究组 & 干预措施
Part 1B: Syfovre and Izervay
Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
干预措施: Izervay™ (Drug)
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
干预措施: RO7669330 (Drug)
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
干预措施: Izervay™ (Drug)
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
干预措施: Syfovre™ (Drug)
Part 1A: Multiple Ascending Dose (MAD)
Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
干预措施: RO7669330 (Drug)
Part 1B: Syfovre and Izervay
Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
干预措施: Syfovre™ (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to a maximum of 34 weeks
Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments
时间窗: Up to a maximum of 34 weeks
The standard ophthalmological assessments that will be conducted may include the following: slit-lamp, indirect ophthalmology, intraocular pressure (IOP), best corrected visual acuity (BCVA), spectral domain optical coherence tomography (SD-OCT), fundus fluorescein angiography (FFA), and color fundus photography (CFP).
次要结局
- Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330(Up to a maximum of Week 24)