Clinical and Functional Retinal Changes Associated With BRAF/MEK Inhibitor Therapy in Patients Wi… (NCT07427953) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Functional Retinal Changes Associated With BRAF/MEK Inhibitor Therapy in Patients With Malignant Melanoma
Slovenia14 participantsStarted 2023-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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