An Ophthalmic Safety Study in Patients With Breast Cancer
Purpose
To assess ophthalmic health in parallel cohorts of patients with breast cancer
Condition
- Ophthalmic Safety in Patients With Breast Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed informed consent in the qualifying study. 2. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures. 3. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study. 4. Meets all the eligibility criteria in the qualifying study
Exclusion Criteria
- Patients not randomized and not receiving study assigned treatment in a qualifying study. 2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents. 3. 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1 from Qualifying Study | ||
| Cohort 2 from Qualifying Study |
Recruiting Locations
Research Site
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Research Site
Pittsburgh, Pennsylvania 15219
Pittsburgh, Pennsylvania 15219
More Details
- NCT ID
- NCT06767462
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
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.