Multicenter Interspecialty Consensus on Experimental Oncology Drug-Related Ocular Adverse Event Reporting

Neel D. Pasricha, Department of Ophthalmology, University of California, San Francisco.
Stella K. Kim, Department of Ophthalmology, University of Texas Health Science Center, Houston.
Asim V. Farooq, Department of Ophthalmology and Visual Science, University of Chicago Medical Center, Chicago, Illinois.
Ethan S. Lindgren, Department of Ophthalmology, University of California, San Francisco.
Rongshan Yan, Department of Ophthalmology, University of California, San Francisco.
Gerami D. Seitzman, Department of Ophthalmology, University of California, San Francisco.
Matilda F. Chan, Department of Ophthalmology, University of California, San Francisco.
Jessica G. Shantha, Francis I. Proctor Foundation, University of California, San Francisco.
Dimitra Skondra, Department of Ophthalmology and Visual Science, University of Chicago Medical Center, Chicago, Illinois.
Bennie H. Jeng, Department of Ophthalmology, Scheie Eye Institute, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Winston D. Chamberlain, Casey Eye Institute, Oregon Health & Science University, Portland.
Kathryn A. Colby, Department of Ophthalmology, New York University Grossman School of Medicine, New York University Langone Health, New York.
Debra A. Goldstein, Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Lucia Sobrin, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston.
Ivana K. Kim, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston.
Kuldev Singh, Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California.
Wiley A. Chambers, Department of Ophthalmology, George Washington University, School of Medicine and Health Sciences, Washington, DC.
William M. Boyd, Division of Ophthalmology, Office of Specialty Medicine, US Food and Drug Administration, Silver Spring, Maryland.
Jordyn Silverstein, Division of Hematology/Oncology, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles.
Paula R. Pohlmann, Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.
Janice Lu, Division of Hematology and Oncology, Department of Medicine, Northwestern University Freiberg School of Medicine, Chicago, Illinois.
Alexa C. Glencer, Department of Surgery, University of California, San Francisco.
Laura A. Huppert, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
A Jo Chien, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
Hope S. Rugo, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
Laura J. Esserman, Department of Surgery, University of California, San Francisco.

Document Type

Journal Article

Publication Date

12-4-2025

Journal

JAMA ophthalmology

DOI

10.1001/jamaophthalmol.2025.3159

Abstract

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.

Department

Ophthalmology

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