Malignant MelanomaNCT07427953
Clinical and Functional Retinal Changes Associated With BRAF/MEK Inhibitor Therapy in Patients With Malignant Melanoma
An observational study of Malignant Melanoma and Drug-Induced Retinopathy, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Drug-Induced Retinopathy
- How many people
- 14 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with histologically confirmed malignant melanoma receiving combined BRAF and MEK inhibitor therapy as part of routine clinical oncologic treatment. Participants were followed prospectively with standardized ophthalmologic examinations to assess structural and functional retinal changes associated with therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Morphological, and Electrophysiological Characteristics of MEK Inhibitor-Associated Retinopathy in Patients Treated With Combined BRAF/MEK Inhibitor Therapy for Malignant Melanoma
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.
Read more
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.
Read the detailed description
This was a prospective, observational cohort study designed to investigate clinical, morphological, and functional retinal changes in patients with histologically confirmed malignant melanoma treated with combined BRAF and MEK inhibitor therapy as part of standard oncologic care.
MEK inhibitor-associated retinopathy (MEKAR) is a recognized adverse effect of MEK inhibitor therapy and is characterized by bilateral, often multifocal serous retinal changes, predominantly involving the outer retinal layers. Although MEKAR is frequently considered reversible, its functional impact and long-term retinal sequelae remain incompletely understood.
The primary objective of this study was to assess the impact of BRAF/MEK inhibitor therapy on retinal structure and function. Secondary objectives included characterization of the clinical course of MEKAR, comparison of MEKAR incidence between different BRAF/MEK inhibitor combinations, and evaluation of persistent retinal changes following completion of therapy.
Adult patients receiving adjuvant or systemic treatment with combined BRAF/MEK inhibitors were enrolled and followed prospectively. Ophthalmologic assessments were performed at baseline, during therapy, and after completion of treatment. Examinations included best-corrected visual acuity testing, contrast sensitivity assessment, microperimetry, multimodal retinal imaging (optical coherence tomography, infrared imaging, and fundus autofluorescence), and electrophysiological testing (electrooculography and multifocal electroretinography, when indicated).
The diagnosis of MEKAR was based on characteristic retinal findings on optical coherence tomography in the absence of alternative ocular or systemic causes. Functional and morphological findings were analyzed longitudinally to assess changes over time and recovery patterns following treatment cessation.
This study was conducted in accordance with ethical standards and was approved by the competent national medical ethics committee. All participants provided informed consent prior to inclusion.
By systematically evaluating retinal structure and function in patients treated with BRAF/MEK inhibitors, this study provides clinically relevant data on MEKAR and supports improved ophthalmologic monitoring of patients receiving targeted melanoma therapy.
- Conditions
- Malignant Melanoma, Drug-Induced Retinopathy
- Keywords
- Malignant melanoma, BRAF Inhibitors, MEK Inhibitors, MEK Inhibitor-Associated Retinopathy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BRAF/MEK Inhibitor-Treated Melanoma Patients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)
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.
Measured: Baseline (prior to initiation of BRAF/MEK inhibitor therapy), up to 24 months after treatment initiation, and up to 6 months after treatment discontinuation
Secondary outcomes (1)
Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR) During BRAF/MEK Inhibitor Therapy
Proportion of participants who develop MEK inhibitor-associated retinopathy (MEKAR) during treatment with combined BRAF/MEK inhibitors, based on characteristic retinal findings detected on optical coherence tomography (OCT).
Measured: From initiation of BRAF/MEK inhibitor therapy up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427953
- Sponsor's protocol ID
- MEKAR-BRAFMEK-ONKO-OFT-01
- Other IDs
- ERID-KSOPR-0085/2023
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Morphological, and Electrophysiological Characteristics of MEK Inhibitor-Associated Retinopathy in Patients Treated With Combined BRAF/MEK Inhibitor Therapy for Malignant Melanoma
- ClinicalTrials.gov ID
- NCT07427953
- Acronym / sponsor ID
- MEKAR-BRAFMEK-ONKO-OFT-01
- Conditions
- Malignant Melanoma, Drug-Induced Retinopathy
- Keywords
- Malignant melanoma, BRAF Inhibitors, MEK Inhibitors, MEK Inhibitor-Associated Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a prospective, observational cohort study designed to investigate clinical, morphological, and functional retinal changes in patients with histologically confirmed malignant melanoma treated with combined BRAF and MEK inhibitor therapy as part of standard oncologic care.
MEK inhibitor-associated retinopathy (MEKAR) is a recognized adverse effect of MEK inhibitor therapy and is characterized by bilateral, often multifocal serous retinal changes, predominantly involving the outer retinal layers. Although MEKAR is frequently considered reversible, its functional impact and long-term retinal sequelae remain incompletely understood.
The primary objective of this study was to assess the impact of BRAF/MEK inhibitor therapy on retinal structure and function. Secondary objectives included characterization of the clinical course of MEKAR, comparison of MEKAR incidence between different BRAF/MEK inhibitor combinations, and evaluation of persistent retinal changes following completion of therapy.
Adult patients receiving adjuvant or systemic treatment with combined BRAF/MEK inhibitors were enrolled and followed prospectively. Ophthalmologic assessments were performed at baseline, during therapy, and after completion of treatment. Examinations included best-corrected visual acuity testing, contrast sensitivity assessment, microperimetry, multimodal retinal imaging (optical coherence tomography, infrared imaging, and fundus autofluorescence), and electrophysiological testing (electrooculography and multifocal electroretinography, when indicated).
The diagnosis of MEKAR was based on characteristic retinal findings on optical coherence tomography in the absence of alternative ocular or systemic causes. Functional and morphological findings were analyzed longitudinally to assess changes over time and recovery patterns following treatment cessation.
This study was conducted in accordance with ethical standards and was approved by the competent national medical ethics committee. All participants provided informed consent prior to inclusion.
By systematically evaluating retinal structure and function in patients treated with BRAF/MEK inhibitors, this study provides clinically relevant data on MEKAR and supports improved ophthalmologic monitoring of patients receiving targeted melanoma therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRAF/MEK Inhibitor-Treated Melanoma Patients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with histologically confirmed malignant melanoma receiving combined BRAF and MEK inhibitor therapy as part of routine clinical oncologic treatment. Participants were followed prospectively with standardized ophthalmologic examinations to assess structural and functional retinal changes associated with therapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)
Time frame: Baseline (prior to initiation of BRAF/MEK inhibitor therapy), up to 24 months after treatment initiation, and up to 6 months after treatment discontinuation
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.
1 secondary outcome
Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR) During BRAF/MEK Inhibitor Therapy
Time frame: From initiation of BRAF/MEK inhibitor therapy up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma and Drug-Induced Retinopathy, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests) (time frame: Baseline (prior to initiation of BRAF/MEK inhibitor therapy), up to 24 months after treatment initiation, and up to 6 months after treatment discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.