Clinical, Morphological, and Electrophysiological Characteristics of MEK Inhibitor-Associated Retinopathy in Patients Treated With Combined BRAF/MEK Inhibitor Therapy for Malignant Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Change in Retinal Structure and Function Parameters (OCT and Visual Function Tests)
时间窗: 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.
次要结局
- Incidence of MEK Inhibitor-Associated Retinopathy (MEKAR) During BRAF/MEK Inhibitor Therapy(From initiation of BRAF/MEK inhibitor therapy up to 24 months)