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.
調査の概要
研究の種類
介入
入学 (推定)
1104
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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)
他の名前：
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実験的：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)
他の名前：
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アクティブコンパレータ：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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硝子体内注射（IVT）によって投与
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Week 104
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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 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 ≥3 Steps from Baseline to Week 104
時間枠：Baseline and Week 104
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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 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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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 ≥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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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Up to approximately Week 52
|
|
Mean Change in BCVA (ETDRS letters) from Baseline Over Time
時間枠：Baseline and 2 Years
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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 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
時間枠：Up to approximately 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 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
時間枠：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
時間枠：Up to approximately 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 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
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Mean Change in BCVA from Baseline to Year 2
時間枠：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
時間枠：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
時間枠：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.
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Up to approximately 2 years
|
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Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 2
時間枠：Baseline and 2 Years
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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 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
時間枠：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.
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Baseline and 2 Years
|
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Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 2
時間枠：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
時間枠：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
時間枠：Baseline to 2 Years
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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 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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Up to approximately 2 years
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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
時間枠：At designated time points (up to approximately 104 weeks)
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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.
|
At designated time points (up to approximately 104 weeks)
|
|
Maximum Plasma Concentration (Cmax) of MK-8748
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月30日
一次修了 (推定)
2028年11月30日
研究の完了 (推定)
2029年11月30日
試験登録日
最初に提出
2026年7月10日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 8748-005
- MK-8748-005 (その他の識別子：MSD)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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