NCT07427953Completed
Clinical and Functional Retinal Changes Associated With BRAF/MEK Inhibitor Therapy in Patients With Malignant Melanoma
Clinical, Morphological, and Electrophysiological Characteristics of MEK Inhibitor-Associated Retinopathy in Patients Treated With Combined BRAF/MEK Inhibitor Therapy for Malignant Melanoma
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 14 (actual)
- First submitted
- 4 Feb 2026
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Melanoma
- NCT number
- NCT07427953
What you commit to
- Study type: Observational
- Participants enrolled: 14
- From 1 Jan 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
- 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.
- Ocular or systemic conditions considered by the investigators to potentially confound study results.
Other
- High myopia greater than -6 diopters.
- Uncontrolled glaucoma.
Who the study is looking for
- 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.
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.