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

NCT07431489 | Completed

• 2 other identifiers: ERIDNPVO-0029/20240120-89/2017/11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Melanoma; MEK Inhibitor-Associated Retinopathy

Keywords

BRAF inhibitor; MEK inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR)

  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.

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

Secondary Outcomes (2)

• Retinal Structural Changes Assessed by Optical Coherence Tomography (OCT)

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

• Change in Best-Corrected Visual Acuity (BCVA)

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

Study Arms (1)

Retinal Monitoring During BRAF/MEK Inhibitor Therapy

EXPERIMENTAL

Participants treated with BRAF/MEK inhibitor combinations undergo structured ophthalmologic examinations and retinal functional testing, including best-corrected visual acuity assessment, contrast sensitivity testing, retinal imaging (OCT, infrared imaging, autofluorescence), microperimetry, electrooculography, and multifocal electroretinography when indicated, to detect and characterize MEK inhibitor-associated retinopathy (MEKAR) and evaluate retinal structural and functional changes during and after therapy.

Other: Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy

Interventions

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.

Retinal Monitoring During BRAF/MEK Inhibitor Therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receiving BRAF/MEK inhibitor therapy undergo structured ophthalmologic examinations and retinal functional testing to detect and characterize MEK inhibitor-associated retinopathy (MEKAR) and evaluate retinal structural and functional alterations.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: November 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)