A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
2026年7月10日 更新者：Merck Sharp & Dohme LLC
A Randomized, Double-Masked, Multicenter, 3-Arm, Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) MK-8748 Compared With Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person.
The main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.
研究概览
研究类型
介入性
注册 (估计的)
1104
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%
- Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)
- For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study
- Has history of stroke (cerebral vascular accident) or myocardial infarction within 180 days to first dose of study intervention
- Has newly diagnosed or previously untreated diabetes mellitus and initiated oral or injectable anti-diabetic medication within 3 months to first dose of study intervention
- Has history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening
- Has any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 90 days of screening
- Has advanced or uncontrolled glaucoma in the study eye
- Has any history of retinal detachment or treatment or surgery for retinal detachment in the study eye
- Has active retinal disease other than the condition under investigation in the study eye
- Has uncontrolled blood pressure at screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MK-8748 Low Dose
Participants receive 5 initial administrations of MK-8748 low dose every 4 weeks (Q4W), then continue to receive MK-8748 low dose every 8 weeks (Q8W) until week 48.
After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.
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Administered by intravitreal injection (IVT)
其他名称：
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实验性的：MK-8748 High Dose
Participants receive 5 initial administrations of MK-8748 high dose every 4 weeks (Q4W), then continue to receive MK-8748 high dose every 8 weeks (Q8W) until week 48.
After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.
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Administered by intravitreal injection (IVT)
其他名称：
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有源比较器：Aflibercept 2 mg
Participants receive 5 initial administrations of aflibercept 2 mg every 4 weeks (Q4W), then continue to receive aflibercept 2mg every 8 weeks (Q8W) until week 100.
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通过玻璃体内注射（IVT）给药
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
大体时间：Baseline and 1 Year
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Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Mean change in ETDRS letters from baseline to Year 1 will be assessed.
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Baseline and 1 Year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
大体时间：Baseline and Week 52
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Central subfield thickness (CST) in the study eye will be measured in microns using optical coherence tomography (OCT).
The mean change in CST from baseline to Year 1 will be presented.
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Baseline and Week 52
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Mean Change in CST from Baseline Over Time
大体时间：Up to approximately 2 years
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Central subfield thickness (CST) in the study eye will be measured in microns using optical coherence tomography (OCT).
The mean change in CST from baseline over time will be presented.
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Up to approximately 2 years
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Time to Absence of Diabetic Macular Edema (DME) at Week 52
大体时间：Up to approximately Week 52
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The absence of Diabetic Macular Edema (DME) is defined as a Central Subfield Thickness (CST) of <300 μm measured using optical coherence tomography (OCT).
The time to absence of Diabetic Macular Edema (DME) in the study eye up to Week 52 will be presented.
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Up to approximately Week 52
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Proportion of Participants with Absence of Intraretinal Fluid Over Time
大体时间：Up to approximately 2 years
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Participants' intraretinal fluid in the study eye will be measured using optical coherence tomography (OCT).
The proportion of participants with absence of intraretinal fluid over time will be presented.
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Up to approximately 2 years
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Proportion of Participants with Absence of Subretinal Fluid Over Time
大体时间：Up to approximately 2 years
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Participants' subretinal fluid in the study eye will be measured using optical coherence tomography (OCT).
The proportion of participants with absence of subretinal fluid over time will be presented.
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Up to approximately 2 years
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Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
大体时间：Up to approximately 2 years
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Participants' subretinal fluid and intraretinal fluid in the study eye will be measured using optical coherence tomography (OCT).
The proportion of participants with absence of intraretinal and subretinal fluid over time will be presented.
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Up to approximately 2 years
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Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1
大体时间：Baseline and 1 Year
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The Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR).
DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable.
All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment.
A lower score represents less advanced diabetic retinopathy.
The proportion of participants with ≥2 step improvement in DRSS score from baseline to year 1 will be presented.
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Baseline and 1 Year
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Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1
大体时间：Baseline and 1 Year
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The Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR).
DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable.
All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment.
A lower score represents less advanced diabetic retinopathy.
The proportion of participants with ≥3 step improvement in DRSS score from baseline to year 1 will be presented.
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Baseline and 1 Year
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Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24
大体时间：Up to approximately Week 24
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Fluorescein Angiography (FA) images will be used to determine the resolution of macular leakage in the study eye, defined as 0 to 1 mm^2.
The proportion of participants with resolution of macular leakage at Week 24 will be presented.
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Up to approximately Week 24
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Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to Week 104
大体时间：Baseline and Week 104
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Central subfield thickness (CST) in the study eye will be measured in microns using optical coherence tomography (OCT).
The mean change in OCT CST from baseline to Week 104 will be presented.
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Baseline and Week 104
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Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to Week 104
大体时间：Baseline and Week 104
|
The Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR).
DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable.
All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment.
A lower score represents less advanced diabetic retinopathy.
The proportion of participants with ≥2 step improvement in DRSS score from baseline to week 104 will be presented.
|
Baseline and Week 104
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Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Week 104
大体时间：Baseline and Week 104
|
The Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR).
DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable.
All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment.
A lower score represents less advanced diabetic retinopathy.
The proportion of participants with ≥3 step improvement in DRSS score from baseline to week 104 will be presented.
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Baseline and Week 104
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Proportion of Participants Without Retinal Fluid at the Foveal Center on OCT at Week 104
大体时间：Up to approximately Week 104
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Optical coherence tomography (OCT) will be used to measure retinal fluid at the foveal center of the study eye.
The proportion of participants without retinal fluid at the foveal center on OCT at Week 104 will be presented.
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Up to approximately Week 104
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Mean change in Foveal Avascular Zone (FAZ) Area on Fluorescein Angiography (FA) from Baseline to Year 1
大体时间：Baseline and 1 Year
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Fluorescein Angiography (FA) images will be used to measure the Foveal Avascular Zone (FAZ) area of the study eye.
The mean change in FAZ area on FA from baseline to year 1 will be presented.
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Baseline and 1 Year
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Proportion of Participants with Reduction in FAZ Area on FA from Baseline to Year 1
大体时间：Baseline and 1 Year
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Fluorescein Angiography (FA) images will be used to measure the Foveal Avascular Zone (FAZ) area of the study eye.
The proportion of participants with reduction of FAZ area on FA from baseline to year 1 will be presented.
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Baseline and 1 Year
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Proportion of Participants Without Retinal Fluid at the Foveal Center at Week 52
大体时间：Up to approximately Week 52
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Participants' retinal fluid in the study eye will be measured using optical coherence tomography (OCT).
The proportion of participants without retinal fluid at the foveal center at week 52 will be presented.
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Up to approximately Week 52
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Mean Number of Intravitreal (IVT) Injections from Week 56 to Week 104
大体时间：Up to approximately 48 Weeks
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The mean number of intravitreal (IVT) Injections from week 56 to week 104 will be presented.
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Up to approximately 48 Weeks
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Proportion of Participants on a Personalized Treatment Interval (PTI) of every 8 weeks (Q8W) at Week 104
大体时间：Up to approximately Week 104
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The proportion of participants on a personalized treatment interval (PTI) of every 8 weeks (Q8W) at Week 104 will be presented.
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Up to approximately Week 104
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Proportion of Participants on a Personalized Treatment Interval (PTI) of every 12 weeks (Q12W) at Week 104
大体时间：Up to approximately Week 104
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The proportion of participants on a personalized treatment interval (PTI) of every 12 weeks (Q12W) at Week 104 will be presented.
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Up to approximately Week 104
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Proportion of Participants on a Personalized Treatment Interval (PTI) of every 16 weeks (Q16W) at Week 104
大体时间：Up to approximately Week 104
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The proportion of participants on a personalized treatment interval (PTI) of every 16 weeks (Q16W) at Week 104 will be presented.
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Up to approximately Week 104
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Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
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Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥5 ETDRS letters from baseline to year 1 will be presented.
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Baseline and 1 Year
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Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥10 ETDRS letters from baseline to year 1 will be presented.
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Baseline and 1 Year
|
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Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥15 ETDRS letters from baseline to year 1 will be presented.
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Baseline and 1 Year
|
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Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥5 ETDRS letters from baseline to year 1 will be presented.
|
Baseline and 1 Year
|
|
Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥10 ETDRS letters from baseline to year 1 will be presented.
|
Baseline and 1 Year
|
|
Proportion of participants who Lose ≥15 ETDRS Letters from Baseline to Year 1
大体时间：Baseline and 1 Year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥15 ETDRS letters from baseline to year 1 will be presented.
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Baseline and 1 Year
|
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Time to gain ≥5 ETDRS Letters Over Time
大体时间：Up to approximately 2 years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The time to gain ≥5 ETDRS letters over time will be presented.
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Up to approximately 2 years
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Time to gain ≥10 ETDRS Letters at Week 52
大体时间：Up to approximately Week 52
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The time to gain ≥10 ETDRS letters up to Week 52 will be presented.
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Up to approximately Week 52
|
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Time to gain ≥15 ETDRS letters at Week 52
大体时间：Up to approximately Week 52
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The time to gain ≥15 ETDRS letters up to Week 52 will be presented.
|
Up to approximately Week 52
|
|
Mean Change in BCVA (ETDRS letters) from Baseline Over Time
大体时间：Baseline and 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The mean change in BCVA (ETDRS) letters from baseline over time will be presented.
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Baseline and 2 Years
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Proportion of Participants with BCVA Snellen Equivalent of 20/20 or Better at Year 1
大体时间：Up to approximately 1 year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The number of letters read correctly, Snellen fraction are converted to a decimal scale.
There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best.
20/20 on the decimal scale is equal to 1.0.
The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity).
The Snellen equivalent of 20/20 or better is defined as ≥84 letters correctly read in the ETDRS chart.
The proportion of participants with BCVA Snellen equivalent of 20/20 or better at year 1 will be presented.
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Up to approximately 1 year
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Proportion of Participants with BCVA Snellen equivalent of 20/200 or Worse at Year 1
大体时间：Up to approximately 1 year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The number of letters read correctly, Snellen fraction are converted to a decimal scale.
There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best.
20/20 on the decimal scale is equal to 1.0.
The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity).
The Snellen equivalent of 20/200 or worse is defined as ≤38 letters correctly read in the ETDRS chart.
The proportion of participants with BCVA Snellen equivalent of 20/200 or Worse at year 1 will be presented.
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Up to approximately 1 year
|
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Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 1
大体时间：Up to approximately 1 year
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The number of letters read correctly, Snellen fraction are converted to a decimal scale.
There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best.
20/20 on the decimal scale is equal to 1.0.
The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity).
The Snellen equivalent of 20/40 or better is defined as ≥69 letters correctly read in the ETDRS chart.
The proportion of participants with BCVA Snellen equivalent of 20/40 or better at year 1 will be presented.
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Up to approximately 1 year
|
|
Mean Change in BCVA from Baseline to Year 2
大体时间：Baseline and Year 2
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Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
Mean change in ETDRS letters from baseline to year 2 will be assessed.
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Baseline and Year 2
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Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 2
大体时间：Up to approximately 2 years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The number of letters read correctly, Snellen fraction are converted to a decimal scale.
There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best.
20/20 on the decimal scale is equal to 1.0.
The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity).
The Snellen equivalent of 20/40 or better is defined as ≥69 letters correctly read in the ETDRS chart.
The proportion of participants with BCVA Snellen equivalent of 20/40 or better at year 2 will be presented.
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Up to approximately 2 years
|
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Proportion of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Year 2
大体时间：Up to approximately 2 years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The number of letters read correctly, Snellen fraction are converted to a decimal scale.
There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best.
20/20 on the decimal scale is equal to 1.0.
The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity).
The Snellen equivalent of 20/200 or worse is defined as ≤38 letters correctly read in the ETDRS chart.
The proportion of participants with BCVA Snellen equivalent of 20/200 or Worse at year 2 will be presented.
|
Up to approximately 2 years
|
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Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 2
大体时间：Baseline and 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥5 ETDRS Letters from baseline to year 2 will be presented.
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Baseline and 2 Years
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Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 2
大体时间：Baseline and 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥10 ETDRS Letters from baseline to year 2 will be presented.
|
Baseline and 2 Years
|
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Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 2
大体时间：Baseline and 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who gain ≥15 ETDRS letters from baseline to year 2 will be presented.
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Baseline and 2 Years
|
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Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 2
大体时间：Baseline to 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥5 ETDRS Letters baseline to year 2 will be presented.
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Baseline to 2 Years
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Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 2
大体时间：Baseline to 2 Years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥10 ETDRS letters from baseline to year 2 will be presented.
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Baseline to 2 Years
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Proportion of Participants who Lose ≥15 ETDRS Letters from Baseline to Year 2
大体时间：Baseline and 2 years
|
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology.
The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity.
The proportion of participants who lose ≥15 ETDRS Letters from baseline to year 2 will be presented.
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Baseline and 2 years
|
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Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 48
大体时间：Baseline and Week 48
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The NEI-VFQ-25 is a validated and reliable 25-item survey that measures the influence of visual disability and visual symptoms on generic health domains (emotional well-being, social functioning and task-oriented domains).
The composite score ranges from 0-100 with the higher score indicating better visual function.
The change from baseline in NEI-VFQ-25 version composite score at week 48 will be presented.
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Baseline and Week 48
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Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 104
大体时间：Baseline and Week 104
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The NEI-VFQ-25 is a validated and reliable 25-item survey that measures the influence of visual disability and visual symptoms on generic health domains (emotional well-being, social functioning and task-oriented domains).
The composite score ranges from 0-100 with the higher score indicating better visual function.
The change from baseline in NEI-VFQ-25 version composite score at week 104 will be presented.
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Baseline and Week 104
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Number of Participants who Experience a Systemic Adverse Events (AEs)
大体时间：Up to approximately 2 years
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who experience a systemic AE will be presented.
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Up to approximately 2 years
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Number of Participants who Experience an Ocular Adverse Events (AEs)
大体时间：Up to approximately 2 years
|
An ocular adverse event (OAE) is defined as any untoward medical occurrence involving the eye or ocular adnexa (including eyelids, conjunctiva, lacrimal apparatus, extraocular muscles, and orbit) that: Occurs or worsens after the first administration of the investigational product (IP) or a study-related ocular procedure, and does not necessarily have a causal relationship with the IP or procedure. OAEs include, but are not limited to, changes in: Symptoms (e.g., ocular pain, photophobia, floaters, blurred vision), Visual function (e.g., best-corrected visual acuity [BCVA], visual field). Intraocular pressure (IOP), Anterior segment findings (e.g., conjunctival hyperemia, keratitis, anterior chamber inflammation), Posterior segment findings (e.g., vitreous inflammation, retinal hemorrhages, retinal tears or detachment, macular edema), or ocular adnexa (e.g., eyelid edema, ptosis). The number of participants who experience an ocular AE will be presented. |
Up to approximately 2 years
|
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Number of Participants who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 2 years
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately 2 years
|
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Number of Participants with Antidrug Antibodies (ADA) to MK-8748
大体时间：At designated time points (up to approximately 104 weeks)
|
Blood samples collected at designated timepoints will be used to determine the ADA response to MK-8748.
The number of participants with ADA to MK-8748 will be presented.
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At designated time points (up to approximately 104 weeks)
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Maximum Plasma Concentration (Cmax) of MK-8748
大体时间：At designated time points (up to approximately 104 weeks)
|
Cmax is defined as the peak concentration over the dosing interval.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-8748.
|
At designated time points (up to approximately 104 weeks)
|
|
Plasma Trough Concentration (Ctrough) of MK-8748
大体时间：At designated time points (up to approximately 104 weeks)
|
Ctrough is defined as the trough concentration.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-8748.
|
At designated time points (up to approximately 104 weeks)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Medical Director、Merck Sharp & Dohme LLC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月30日
初级完成 (估计的)
2028年11月30日
研究完成 (估计的)
2029年11月30日
研究注册日期
首次提交
2026年7月10日
首先提交符合 QC 标准的
2026年7月10日
首次发布 (实际的)
2026年7月15日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月10日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 8748-005
- MK-8748-005 (其他标识符：MSD)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.