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NCT07431489Completed

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

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

Source: ClinicalTrials.gov · Last updated 24 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
10 Feb 2026
Start date
1 Nov 2023
Primary completion date
31 Jan 2025
Lead sponsor
Institute of Oncology Ljubljana
Diseases
Melanoma
NCT number
NCT07431489

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 1 Nov 2023 to the primary completion date, 31 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Retinal diseases (e.g., central serous chorioretinopathy).
  • Macular disorders.
  • Other ocular or systemic diseases that could influence study results.

Other

  • Intraocular inflammation.
  • Uncontrolled glaucoma.
  • High myopia (\> -6 diopters).

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Oncology Ljubljana
Coordinator of this site? Confirm its status
LjubljanaSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.