Clinical and Functional Retinal Changes Associated With BRAF/MEK Inhibitor Therapy in Patients With Malignant Melanoma

NCT07427953 | Completed

• 2 other identifiers: MEKAR-BRAFMEK-ONKO-OFT-01ERID-KSOPR-0085/2023
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with malignant melanoma are increasingly treated with combined BRAF and MEK inhibitor therapy. Although this treatment has significantly improved survival outcomes, it has been associated with specific retinal changes known as MEK inhibitor-associated retinopathy (MEKAR). This observational study aimed to evaluate structural and functional retinal changes in patients treated with BRAF/MEK inhibitors. The study focused on identifying clinical characteristics of MEKAR, assessing retinal function and morphology during therapy, and examining the course of retinal changes after completion of treatment. Patients undergoing standard oncologic treatment with BRAF/MEK inhibitors were followed prospectively with regular ophthalmologic examinations, including visual function testing, retinal imaging, and electrophysiological assessments. The results of this study contribute to a better understanding of retinal alterations associated with BRAF/MEK inhibitor therapy and may support improved recognition, monitoring, and management of MEKAR in clinical practice.

Conditions

Malignant Melanoma; Drug-Induced Retinopathy

Keywords

Malignant melanoma; BRAF Inhibitors; MEK Inhibitors; MEK Inhibitor-Associated Retinopathy

Outcome Measures

Primary Outcomes (1)

• Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)

  Structural and functional retinal changes assessed using optical coherence tomography (OCT) and ophthalmologic functional testing. Outcomes include OCT-detected retinal abnormalities consistent with MEK inhibitor-associated retinopathy (MEKAR), best-corrected visual acuity (BCVA), contrast sensitivity, microperimetry, and electrophysiological assessments (electrooculography and multifocal electroretinography, when performed). Each assessment will be analyzed and reported separately according to its measurement scale.

  Baseline (prior to initiation of BRAF/MEK inhibitor therapy), up to 24 months after treatment initiation, and up to 6 months after treatment discontinuation

Secondary Outcomes (1)

• Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR) During BRAF/MEK Inhibitor Therapy

  From initiation of BRAF/MEK inhibitor therapy up to 24 months

Study Arms (1)

BRAF/MEK Inhibitor-Treated Melanoma Patients

Adult patients with histologically confirmed malignant melanoma treated with combined BRAF and MEK inhibitor therapy as part of standard oncologic care. Participants were followed prospectively with ophthalmologic examinations to assess structural and functional retinal changes associated with therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult patients with histologically confirmed malignant melanoma receiving combined BRAF and MEK inhibitor therapy as part of routine clinical oncologic treatment. Participants were followed prospectively with standardized ophthalmologic examinations to assess structural and functional retinal changes associated with therapy.

You may qualify if:

• Adults aged 18 years or older.
• Histologically confirmed malignant melanoma.
• Treatment with combined BRAF and MEK inhibitor therapy as part of standard oncologic care.
• Ability to undergo ophthalmologic examinations and retinal imaging.
• Written informed consent provided prior to participation.

You may not qualify if:

• Pre-existing retinal disease that could interfere with assessment of retinal changes (e.g., central serous chorioretinopathy, macular degeneration).
• History of ocular conditions affecting the macula unrelated to BRAF/MEK inhibitor therapy.
• High myopia greater than -6 diopters.
• Uncontrolled glaucoma.
• Ocular or systemic conditions considered by the investigators to potentially confound study results.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 23, 2026
• Study Start: January 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)