A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
2026년 7월 10일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
1104
단계
- 3단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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)
다른 이름들:
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실험적: 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)
다른 이름들:
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활성 비교기: 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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유리체강내 주사(IVT)로 투여
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline and Week 104
|
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
기간: 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.
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 1
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
|
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 2
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
|
|
Number of Participants who Discontinue Study Treatment Due to an AE
기간: 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
|
|
Number of Participants with Antidrug Antibodies (ADA) to MK-8748
기간: 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.
|
At designated time points (up to approximately 104 weeks)
|
|
Maximum Plasma Concentration (Cmax) of MK-8748
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 30일
기본 완료 (추정된)
2028년 11월 30일
연구 완료 (추정된)
2029년 11월 30일
연구 등록 날짜
최초 제출
2026년 7월 10일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 8748-005
- MK-8748-005 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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