A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 160
- 试验地点
- 50
- 主要终点
- Visual Acuity Testing (Snellen units)
研究概览
简要总结
To assess ophthalmic health in parallel cohorts of patients with breast cancer
详细描述
This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each.
To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent in the qualifying study.
- •Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures.
- •Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study.
- •Meets all the eligibility criteria in the qualifying study
排除标准
- •Patients not randomized and not receiving study assigned treatment in a qualifying study.
- •Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents.
- •Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements
研究组 & 干预措施
Cohort 1 from Qualifying Study
Cohort 2 from Qualifying Study
结局指标
主要结局
Visual Acuity Testing (Snellen units)
时间窗: Ophthalmic review by central reader until 28 days after End of Study visit.
To detect potential impairment in central vision in patients with breast cancer.
Slit Lamp examination (normal/abnormal)
时间窗: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
To detect any corneal changes or lens changes (eg, cataracts) that could impact high and low contrast acuity/visual field in patients with breast cancer.
Optical Coherence Tonometry (μm)
时间窗: Ophthalmic review by central reader until 28 days after End of Study visit.
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Fundus Examination (normal/abnormal)
时间窗: Ophthalmic review by central reader until 28 days after End of Study visit.
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
次要结局
- Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)(Until 28 days after the End of Study visit)