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Multicenter Interspecialty Consensus on Experimental Oncology Drug-Related Ocular Adverse Event Reporting
Neel D Pasricha1,2, Stella K Kim3, Asim V Farooq4
1Department of Ophthalmology, University of California, San Francisco.
Importance:
The current ocular Common Terminology Criteria for Adverse Events (CTCAE) mix eye signs with symptoms and lack standardized clinical photographs and experimental oncology drug dose modification recommendations. Robust reporting of ocular adverse events (AEs) is important to maintain patient safety and to guide the development of novel efficacious drugs.
Objective:
To develop improved ocular AE grading scales to reliably evaluate and grade ocular AEs in patients on experimental oncology drug therapy and to provide clear drug dose modification recommendations.
Design, Setting, And Participants:
A collaborative multicenter interspecialty working group consisting of oncologists and academic ophthalmologists from 11 academic centers in the US and ophthalmologists from the US Food and Drug Administration was assembled in February 2023 to form a consensus on new experimental oncology drug-related ocular AE grading scales. The grading scales were released in June 2023.
Main Outcomes And Measures:
Expert consensus on novel experimental oncology drug-related ocular AE grading scales.
Results:
Six experimental oncology drug-related ocular AE grading scales were developed with agreement from ophthalmologists and oncologists for use in antibody-drug conjugate clinical trials: visual acuity, eye symptoms, cornea, conjunctiva/sclera, anterior chamber, and retina/posterior segment.
Conclusions And Relevance:
The new experimental oncology drug-related ocular AE grading scales developed by the consensus panel were developed to be more concise, containing photographs where applicable, and to provide clear drug dose modification recommendations compared with the previous CTCAE. Use of these ocular AE grading scales may allow for more objective and consistent incidence measurements of ocular AEs throughout clinical trials and postmarketing, potentially facilitating safe testing of novel agents that may cause eye toxicity.
Insights
New ocular grading scales improve the reporting of adverse events (AEs) in patients receiving experimental oncology drugs. These standardized scales enhance patient safety and guide the development of novel cancer therapies.
Area of Science:
- Ophthalmology
- Oncology
- Clinical Trials
Background:
- Current ocular Common Terminology Criteria for Adverse Events (CTCAE) lack standardization, mixing signs and symptoms, and omitting dose modification guidance.
- Robust reporting of ocular adverse events (AEs) is crucial for patient safety and developing effective oncology drugs.
Purpose of the Study:
- To develop improved ocular AE grading scales for evaluating AEs in patients undergoing experimental oncology drug therapy.
- To provide clear drug dose modification recommendations for ocular AEs.
Main Methods:
- A collaborative multicenter working group of oncologists and ophthalmologists was formed in February 2023.
- Expert consensus was reached on novel experimental oncology drug-related ocular AE grading scales, which were released in June 2023.
Main Results:
- Six novel ocular AE grading scales were developed for antibody-drug conjugate clinical trials: visual acuity, eye symptoms, cornea, conjunctiva/sclera, anterior chamber, and retina/posterior segment.
- These scales incorporate standardized clinical photographs where applicable.
Conclusions:
- The new scales are more concise than previous CTCAE and include clear drug dose modification recommendations.
- These grading scales promote objective and consistent measurement of ocular AEs, aiding safe testing of novel oncology agents.
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