Malignant MelanomaNCT07431489
Retinal Structural and Functional Changes in Patients Treated With BRAF/MEK Inhibitors
A study testing Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy in people with Malignant Melanoma and MEK Inhibitor-Associated Retinopathy, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, MEK Inhibitor-Associated Retinopathy
- What is being tested?
- Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Nov 2023to 31 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structural and Functional Retinal Alterations in Patients Under Treatment With BRAF/MEK Inhibitors
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.
Read the detailed description
BRAF/MEK inhibitor combinations are commonly used in the treatment of malignant melanoma, including adjuvant and metastatic settings. During therapy, some patients develop retinal structural and functional alterations referred to as MEK inhibitor-associated retinopathy (MEKAR).
This study is designed as a prospective, longitudinal, interventional clinical study conducted at the Institute of Oncology Ljubljana. All eligible adult patients with histologically confirmed malignant melanoma who initiate treatment with a BRAF/MEK inhibitor combination (dabrafenib/trametinib or vemurafenib/cobimetinib) are invited to participate.
Participants undergo standardized ophthalmologic evaluations before initiation of therapy, two weeks after therapy initiation, and during treatment if visual symptoms occur. When MEKAR is diagnosed, follow-up examinations are performed at least six months after completion of therapy.
The ophthalmologic assessment includes best-corrected visual acuity measurement, contrast sensitivity testing, slit-lamp examination after pharmacologic dilation, retinal imaging using optical coherence tomography (OCT), infrared and autofluorescence imaging, microperimetry, and electrooculography. In patients receiving adjuvant therapy who develop MEKAR involving the fovea, multifocal electroretinography is additionally performed at diagnosis and repeated after treatment completion.
The study evaluates the incidence of MEKAR, changes in visual function, structural retinal alterations, differences between BRAF/MEK inhibitor combinations, and potential long-term retinal outcomes after therapy discontinuation.
- Being tested
- Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy
- Keywords
- BRAF inhibitor, MEK inhibitor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor TherapyOther
Participants treated with BRAF/MEK inhibitor combinations undergo ophthalmologic evaluation and retinal functional testing, including best-corrected visual acuity assessment, contrast sensitivity testing, slit-lamp examination, retinal imaging (OCT, infrared imaging, autofluorescence imaging), microperimetry, and electrophysiological testing (electrooculography and multifocal electroretinography when indicated) to detect MEK inhibitor-associated retinopathy (MEKAR) and assess retinal structural and functional alterations during and after therapy.
| Study group | Role | What they receive |
|---|---|---|
| Retinal Monitoring During BRAF/MEK Inhibitor Therapy | Experimental | 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. Receives: Other: Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR)
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.
Measured: Baseline (Day 0) through end of treatment (up to 14 months)
Secondary outcomes (2)
Retinal Structural Changes Assessed by Optical Coherence Tomography (OCT)
Retinal structural alterations assessed by optical coherence tomography (OCT), including presence of neurosensory retinal detachment and other MEKAR-related changes.
Measured: Baseline (Day 0); Week 2; and up to 14 months
Change in Best-Corrected Visual Acuity (BCVA)
Change in best-corrected visual acuity (BCVA) measured during ophthalmologic examinations to assess visual function during BRAF/MEK inhibitor therapy.
Measured: Baseline (Day 0); Week 2; and up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receiving BRAF/MEK inhibitor therapy undergo structured ophthalmologic examinations and retinal functional testing to detect and characterize MEK inhibitor-associated retinopathy (MEKAR) and evaluate retinal structural and functional alterations.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07431489
- Sponsor's protocol ID
- ERIDNPVO-0029/2024
- Other IDs
- 0120-89/2017/11
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Retinal Alterations in Patients Under Treatment With BRAF/MEK Inhibitors
- ClinicalTrials.gov ID
- NCT07431489
- Acronym / sponsor ID
- ERIDNPVO-0029/2024
- Keywords
- BRAF inhibitor, MEK inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 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 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.
Detailed description
BRAF/MEK inhibitor combinations are commonly used in the treatment of malignant melanoma, including adjuvant and metastatic settings. During therapy, some patients develop retinal structural and functional alterations referred to as MEK inhibitor-associated retinopathy (MEKAR).
This study is designed as a prospective, longitudinal, interventional clinical study conducted at the Institute of Oncology Ljubljana. All eligible adult patients with histologically confirmed malignant melanoma who initiate treatment with a BRAF/MEK inhibitor combination (dabrafenib/trametinib or vemurafenib/cobimetinib) are invited to participate.
Participants undergo standardized ophthalmologic evaluations before initiation of therapy, two weeks after therapy initiation, and during treatment if visual symptoms occur. When MEKAR is diagnosed, follow-up examinations are performed at least six months after completion of therapy.
The ophthalmologic assessment includes best-corrected visual acuity measurement, contrast sensitivity testing, slit-lamp examination after pharmacologic dilation, retinal imaging using optical coherence tomography (OCT), infrared and autofluorescence imaging, microperimetry, and electrooculography. In patients receiving adjuvant therapy who develop MEKAR involving the fovea, multifocal electroretinography is additionally performed at diagnosis and repeated after treatment completion.
The study evaluates the incidence of MEKAR, changes in visual function, structural retinal alterations, differences between BRAF/MEK inhibitor combinations, and potential long-term retinal outcomes after therapy discontinuation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receiving BRAF/MEK inhibitor therapy undergo structured ophthalmologic examinations and retinal functional testing to detect and characterize MEK inhibitor-associated retinopathy (MEKAR) and evaluate retinal structural and functional alterations.
| Arm | Type | Receives |
|---|---|---|
| Retinal Monitoring During BRAF/MEK Inhibitor Therapy | Experimental | Other: Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Intraocular inflammation.
- Uncontrolled glaucoma.
- Retinal diseases (e.g., central serous chorioretinopathy).
- Macular disorders.
- High myopia (> -6 diopters).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor TherapyParticipants treated with BRAF/MEK inhibitor combinations undergo ophthalmologic evaluation and retinal functional testing, including best-corrected visual acuity assessment, contrast sensitivity testing, slit-lamp examination, retinal imaging (OCT, infrared imaging, autofluorescence imaging), microperimetry, and electrophysiological testing (electrooculography and multifocal electroretinography when indicated) to detect MEK inhibitor-associated retinopathy (MEKAR) and assess retinal structural and functional alterations during and after therapy. | Other | Retinal Monitoring During BRAF/MEK Inhibitor Therapy |
Primary outcome
Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR)
Time frame: Baseline (Day 0) through end of treatment (up to 14 months)
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.
2 secondary outcomes
Retinal Structural Changes Assessed by Optical Coherence Tomography (OCT)
Time frame: Baseline (Day 0); Week 2; and up to 14 months
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline (Day 0); Week 2; and up to 14 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 24 Feb 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?
A study testing Ophthalmologic Retinal Monitoring During BRAF/MEK Inhibitor Therapy in people with Malignant Melanoma and MEK Inhibitor-Associated 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 4 inclusion and 6 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 24 Feb 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?
Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR) (time frame: Baseline (Day 0) through end of treatment (up to 14 months)). 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 24 Feb 2026.