An Ophthalmic Safety Study in Patients With Breast Cancer

Recruiting

• Conditions: Ophthalmic Safety in Patients With Breast Cancer

• Registration Number: NCT06767462
• Lead Sponsor: AstraZeneca

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2025-01-08
• Status Verified: 2025-03
• Study Start: 2025-03-04
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-07-06
• Study Completion: 2027-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuity Testing (Snellen units)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
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	To assess the ophthalmic safety in patients with breast cancer.

Trial Locations

Locations (1)

Research Site; 🇪🇸 Salamanca, Spain