Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| MEK Inhibitor-Associated Retinopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Retinal Monitoring During BRAF/MEK Inhibitor Therapy
- description
- 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.
- interventionNames
- Other: Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy
Primary outcomes (1)
- measure
- Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR)
- timeFrame
- Baseline (Day 0) through end of treatment (up to 14 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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