White Paper

Considering Ocular Safety: Key Insights into Conducting Ophthalmic Assessments for Clinical Trials

Systemic therapies, including oncology, neurology, infectious disease, and cardiovascular treatments, can carry under‑recognized risks of ocular toxicity, making proactive vision safety planning essential for protecting patients and meeting regulatory expectations. This white paper offers a clear guide for non‑ophthalmic drug developers on when ocular assessments are warranted, how to design scientifically justified protocols, and how to execute them efficiently through qualified sites, consistent imaging, and expert interpretation.

Considering Ocular Safety: Key Insights into Conducting Ophthalmic Assessments for Clinical Trials
Authors:
Slakter

Dr. Slakter is an internationally recognized retinal disease specialist with over 30 years of experience in clinical practice. He created the Digital…

Hanna Rodriguez Coleman, M.D.

Dr. Hanna Rodriguez Coleman is our Associate Medical Director for Ophthalmology with over 20 years of experience. Dr. Coleman is a Clinical Professor…

Stephanie Attebery

Stephanie Attebery is our Director of Global Services with over 20 years of experience in ophthalmic imaging operations and clinical trial execution.…

Laura Guzman

Laura Guzman has been involved in QA activities with Voiant since 2009; and is currently the Vice President of Quality and Compliance, providing overs…

What's inside:

Understanding Ocular Toxicities
Why common eye risks related to systemic therapies matter for clinical programs
Designing & Implementing Ocular Safety Studies
How to build and operationalize a fit‑for‑purpose monitoring strategy
Evaluating Imaging & Interpreting Results
How to ensure high‑quality assessments through expert reading and reliable data

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