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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.