NCT07705555招募中3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 9
- 主要终点
- Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MK-8748 Low Dose
Experimental
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.
干预措施: MK-8748 (Drug)
MK-8748 High Dose
Experimental
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.
干预措施: MK-8748 (Drug)
Aflibercept 2 mg
Active Comparator
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.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
时间窗: 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. Mean change in ETDRS letters from baseline to Year 1 will be assessed.
次要结局
- Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52(Baseline and Week 52)
- Mean Change in CST from Baseline Over Time(Up to approximately 2 years)
- Time to Absence of Diabetic Macular Edema (DME) at Week 52(Up to approximately Week 52)
- Proportion of Participants with Absence of Intraretinal Fluid Over Time(Up to approximately 2 years)
- Proportion of Participants with Absence of Subretinal Fluid Over Time(Up to approximately 2 years)
- Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time(Up to approximately 2 years)
- Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24(Up to approximately Week 24)
- Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to Week 104(Baseline and Week 104)
- Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to Week 104(Baseline and Week 104)
- Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Week 104(Baseline and Week 104)
- Proportion of Participants Without Retinal Fluid at the Foveal Center on OCT at Week 104(Up to approximately Week 104)
- Mean change in Foveal Avascular Zone (FAZ) Area on Fluorescein Angiography (FA) from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants with Reduction in FAZ Area on FA from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants Without Retinal Fluid at the Foveal Center at Week 52(Up to approximately Week 52)
- Mean Number of Intravitreal (IVT) Injections from Week 56 to Week 104(Up to approximately 48 Weeks)
- Proportion of Participants on a Personalized Treatment Interval (PTI) of every 8 weeks (Q8W) at Week 104(Up to approximately Week 104)
- Proportion of Participants on a Personalized Treatment Interval (PTI) of every 12 weeks (Q12W) at Week 104(Up to approximately Week 104)
- Proportion of Participants on a Personalized Treatment Interval (PTI) of every 16 weeks (Q16W) at Week 104(Up to approximately Week 104)
- Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Proportion of participants who Lose ≥15 ETDRS Letters from Baseline to Year 1(Baseline and 1 Year)
- Time to gain ≥5 ETDRS Letters Over Time(Up to approximately 2 years)
- Time to gain ≥10 ETDRS Letters at Week 52(Up to approximately Week 52)
- Time to gain ≥15 ETDRS letters at Week 52(Up to approximately Week 52)
- Mean Change in BCVA (ETDRS letters) from Baseline Over Time(Baseline and 2 Years)
- Proportion of Participants with BCVA Snellen Equivalent of 20/20 or Better at Year 1(Up to approximately 1 year)
- Proportion of Participants with BCVA Snellen equivalent of 20/200 or Worse at Year 1(Up to approximately 1 year)
- Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 1(Up to approximately 1 year)
- Mean Change in BCVA from Baseline to Year 2(Baseline and Year 2)
- Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 2(Up to approximately 2 years)
- Proportion of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Year 2(Up to approximately 2 years)
- Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 2(Baseline and 2 Years)
- Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 2(Baseline and 2 Years)
- Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 2(Baseline and 2 Years)
- Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 2(Baseline to 2 Years)
- Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 2(Baseline to 2 Years)
- Proportion of Participants who Lose ≥15 ETDRS Letters from Baseline to Year 2(Baseline and 2 years)
- Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 48(Baseline and Week 48)
- Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 104(Baseline and Week 104)
- Number of Participants who Experience a Systemic Adverse Events (AEs)(Up to approximately 2 years)
- Number of Participants who Experience an Ocular Adverse Events (AEs)(Up to approximately 2 years)
- Number of Participants who Discontinue Study Treatment Due to an AE(Up to approximately 2 years)
- Number of Participants with Antidrug Antibodies (ADA) to MK-8748(At designated time points (up to approximately 104 weeks))
- Maximum Plasma Concentration (Cmax) of MK-8748(At designated time points (up to approximately 104 weeks))
- Plasma Trough Concentration (Ctrough) of MK-8748(At designated time points (up to approximately 104 weeks))
研究者
研究点 (9)
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