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NCT Number: NCT07431489

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

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.

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Key information

Conditions

Malignant Melanoma MEK Inhibitor-Associated Retinopathy Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

BRAF/MEK inhibitor combinations are commonly used in the treatment of malignant melanoma, including adjuvant and metastatic settings. During therapy, some patients develop retinal structural and functional alterations referred to as MEK inhibitor-associated retinopathy (MEKAR).

This study is designed as a prospective, longitudinal, interventional clinical study conducted at the Institute of Oncology Ljubljana. All eligible adult patients with histologically confirmed malignant melanoma who initiate treatment with a BRAF/MEK inhibitor combination (dabrafenib/trametinib or vemurafenib/cobimetinib) are invited to participate.

Participants undergo standardized ophthalmologic evaluations before initiation of therapy, two weeks after therapy initiation, and during treatment if visual symptoms occur. When MEKAR is diagnosed, follow-up examinations are performed at least six months after completion of therapy.

The ophthalmologic assessment includes best-corrected visual acuity measurement, contrast sensitivity testing, slit-lamp examination after pharmacologic dilation, retinal imaging using optical coherence tomography (OCT), infrared and autofluorescence imaging, microperimetry, and electrooculography. In patients receiving adjuvant therapy who develop MEKAR involving the fovea, multifocal electroretinography is additionally performed at diagnosis and repeated after treatment completion.

The study evaluates the incidence of MEKAR, changes in visual function, structural retinal alterations, differences between BRAF/MEK inhibitor combinations, and potential long-term retinal outcomes after therapy discontinuation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older
  • Histologically confirmed malignant melanoma
  • Treatment with a BRAF/MEK inhibitor combination (dabrafenib/trametinib or vemurafenib/cobimetinib)
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Intraocular inflammation.
  • Uncontrolled glaucoma.
  • Retinal diseases (e.g., central serous chorioretinopathy).
  • Macular disorders.
  • High myopia (> -6 diopters).
  • Other ocular or systemic diseases that could influence study results.

Treatment and study plan

Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy

Other

Participants treated with BRAF/MEK inhibitor combinations undergo ophthalmologic evaluation and retinal functional testing, including best-corrected visual acuity assessment, contrast sensitivity testing, slit-lamp examination, retinal imaging (OCT, infrared imaging, autofluorescence imaging), microperimetry, and electrophysiological testing (electrooculography and multifocal electroretinography when indicated) to detect MEK inhibitor-associated retinopathy (MEKAR) and assess retinal structural and functional alterations during and after therapy.

Primary outcomes

  1. Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR)

    Time frame: Baseline (Day 0) through end of treatment (up to 14 months)

    Incidence of MEK inhibitor-associated retinopathy (MEKAR), defined as the proportion of participants who develop MEKAR during BRAF/MEK inhibitor therapy based on predefined clinical criteria and optical coherence tomography (OCT) findings.

Secondary outcomes

  1. Retinal Structural Changes Assessed by Optical Coherence Tomography (OCT)

    Time frame: Baseline (Day 0); Week 2; and up to 14 months

    Retinal structural alterations assessed by optical coherence tomography (OCT), including presence of neurosensory retinal detachment and other MEKAR-related changes.

  2. Change in Best-Corrected Visual Acuity (BCVA)

    Time frame: Baseline (Day 0); Week 2; and up to 14 months

    Change in best-corrected visual acuity (BCVA) measured during ophthalmologic examinations to assess visual function during BRAF/MEK inhibitor therapy.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Structural and Functional Retinal Alterations in Patients Under Treatment With BRAF/MEK Inhibitors

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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