An Ophthalmic Safety Study in Patients With Breast Cancer

AstraZeneca

Status: Enrolling

Conditions: Ophthalmic Safety in Patients With Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06767462

D853AC00001

Details and patient eligibility

About

To assess ophthalmic health in parallel cohorts of patients with breast cancer

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

1. 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

Trial design

160 participants in 2 patient groups

Cohort 1 from Qualifying Study

Cohort 2 from Qualifying Study