An Ophthalmic Safety Study in Patients With Breast Cancer

NCT06767462 · tracked via the Priya Life Science USA tracker

Sponsor

AstraZeneca

Phase

Observational

Started

2025-03-05

Last updated

2026-06-16

Condition(s) studied

Ophthalmic Safety in Patients With Breast Cancer

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

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

Primary outcome measure(s)

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.

Trial sites (50)

Facility	City	Region
Research Site	La Jolla	California
Research Site	Palo Alto	California
Research Site	Iowa City	Iowa
Research Site	Winston-Salem	North Carolina
Research Site	Clairton	Pennsylvania
Research Site	Pittsburgh	Pennsylvania
Research Site	Sioux Falls	South Dakota
Research Site	Bartlett	Tennessee
Research Site	Houston	Texas
Research Site	CABA	Argentina
Research Site	Córdoba	Argentina
Research Site	Leuven	Belgium
Research Site	Liège	Belgium
Research Site	Alfenas	Brazil
Research Site	Belo Horizonte	Brazil
Research Site	Curitiba	Brazil
Research Site	Lajeado	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Pouso Alegre	Brazil
Research Site	São Paulo	Brazil
Research Site	Sorocaba	Brazil
Research Site	Três Lagoas	Brazil
Research Site	Vitória	Brazil
Research Site	Montreal	Quebec
Research Site	Montreal	Quebec
Research Site	Santiago	Chile
Research Site	Santiago	Chile
Research Site	Ashdod	Israel
Research Site	Nahariya	Israel
Research Site	Lodz	Poland
Research Site	Amadora	Portugal
Research Site	Braga	Portugal
Research Site	Seoul	South Korea
Research Site	Badalona	Spain
Research Site	Barcelona	Spain
Research Site	Barcelona	Spain
Research Site	Barcelona	Spain
Research Site	Girona	Spain
Research Site	L'Hospitalet de Llobregat	Spain
Research Site	Leganés	Spain

+ 10 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767462 on ClinicalTrials.gov ↗ ← All trials in the USA