Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Drug-Induced Retinopathy | — | UNRESOLVED | — |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- BRAF/MEK Inhibitor-Treated Melanoma Patients
- description
- Adult patients with histologically confirmed malignant melanoma treated with combined BRAF and MEK inhibitor therapy as part of standard oncologic care. Participants were followed prospectively with ophthalmologic examinations to assess structural and functional retinal changes associated with therapy.
Primary outcomes (1)
- measure
- Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)
- timeFrame
- Baseline (prior to initiation of BRAF/MEK inhibitor therapy), up to 24 months after treatment initiation, and up to 6 months after treatment discontinuation
- description
- Structural and functional retinal changes assessed using optical coherence tomography (OCT) and ophthalmologic functional testing. Outcomes include OCT-detected retinal abnormalities consistent with MEK inhibitor-associated retinopathy (MEKAR), best-corrected visual acuity (BCVA), contrast sensitivity, microperimetry, and electrophysiological assessments (electrooculography and multifocal electroretinography, when performed). Each assessment will be analyzed and reported separately according to its measurement scale.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * High myopia greater than -6 diopters. * Uncontrolled glaucoma. * Ocular or systemic conditions considered by the investigators to potentially confound study results.
References
Publications (0)
Data not yet available