Clinical Trial

Retinal Structural and Functional Changes in Patients Treated With BRAF/MEK Inhibitors

Completed
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Summary
Patients treated with BRAF/MEK inhibitor combinations for malignant melanoma may develop retinal changes known as MEK inhibitor-associated retinopathy (MEKAR). These changes can affect the structure and function of the retina and may cause visual symptoms. This prospective interventional study evaluates structural and functional retinal alterations in patients receiving BRAF/MEK inhibitor therapy. The study aims to determine how often MEKAR occurs, describe its clinical characteristics and course, compare its incidence between different BRAF/MEK inhibitor combinations, and assess possible long-term retinal changes after treatment discontinuation. Participants undergo structured ophthalmologic examinations, including visual acuity testing, retinal imaging, and functional retinal testing before treatment, two weeks after treatment initiation, during therapy if visual symptoms occur, and, when indicated, after treatment completion.
Trial Details
NCT Number NCT07431489
Lead Sponsor Institute of Oncology Ljubljana
Conditions Malignant Melanoma, MEK Inhibitor-Associated Retinopathy
Enrollment 30 participants
Start Date 2023-11-01
Primary Completion 2025-01-31 (estimated)
Study Completion 2025-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-24