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Melanoma Drug's eye impact revealed in new study

NCT ID NCT07427953

Knowledge-focused Sponsor: Institute of Oncology Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 14 adults with melanoma who were taking a combination of BRAF and MEK inhibitor drugs. The goal was to understand how these drugs can affect the retina, the light-sensitive part of the eye. Researchers used eye exams and special imaging to track changes over time. The findings help doctors better recognize and manage these eye side effects during treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

14 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma toxic maculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug-induced retinopathy Malignant melanoma MEK inhibitor-associated retinopathy Retinal toxicity

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

More trials for these conditions

Other studies related to the condition(s) this trial covers.