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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)

10 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1104

Faza

  • Faza 3

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: MK-8748
Administered by intravitreal injection (IVT)
Inne nazwy:
  • Tiespectus
  • EYE201
Eksperymentalny: 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.
Lek: MK-8748
Administered by intravitreal injection (IVT)
Inne nazwy:
  • Tiespectus
  • EYE201
Aktywny komparator: 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.
Lek: Aflibercept
Podawane poprzez iniekcję doszklistkową (IVT)
Inne nazwy:
  • Eylea

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Ramy czasowe: 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.
Baseline and 1 Year

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Ramy czasowe: Baseline and Week 52
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.
Baseline and Week 52
Mean Change in CST from Baseline Over Time
Ramy czasowe: Up to approximately 2 years
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.
Up to approximately 2 years
Time to Absence of Diabetic Macular Edema (DME) at Week 52
Ramy czasowe: Up to approximately Week 52
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.
Up to approximately Week 52
Proportion of Participants with Absence of Intraretinal Fluid Over Time
Ramy czasowe: Up to approximately 2 years
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.
Up to approximately 2 years
Proportion of Participants with Absence of Subretinal Fluid Over Time
Ramy czasowe: Up to approximately 2 years
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.
Up to approximately 2 years
Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Ramy czasowe: Up to approximately 2 years
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.
Up to approximately 2 years
Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1
Ramy czasowe: Baseline and 1 Year
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.
Baseline and 1 Year
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1
Ramy czasowe: Baseline and 1 Year
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.
Baseline and 1 Year
Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24
Ramy czasowe: Up to approximately Week 24
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.
Up to approximately Week 24
Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to Week 104
Ramy czasowe: 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.
Baseline and Week 104
Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to Week 104
Ramy czasowe: 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
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Week 104
Ramy czasowe: 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.
Baseline and Week 104
Proportion of Participants Without Retinal Fluid at the Foveal Center on OCT at Week 104
Ramy czasowe: Up to approximately Week 104
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.
Up to approximately Week 104
Mean change in Foveal Avascular Zone (FAZ) Area on Fluorescein Angiography (FA) from Baseline to Year 1
Ramy czasowe: Baseline and 1 Year
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.
Baseline and 1 Year
Proportion of Participants with Reduction in FAZ Area on FA from Baseline to Year 1
Ramy czasowe: Baseline and 1 Year
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.
Baseline and 1 Year
Proportion of Participants Without Retinal Fluid at the Foveal Center at Week 52
Ramy czasowe: Up to approximately Week 52
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.
Up to approximately Week 52
Mean Number of Intravitreal (IVT) Injections from Week 56 to Week 104
Ramy czasowe: Up to approximately 48 Weeks
The mean number of intravitreal (IVT) Injections from week 56 to week 104 will be presented.
Up to approximately 48 Weeks
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 8 weeks (Q8W) at Week 104
Ramy czasowe: Up to approximately Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 8 weeks (Q8W) at Week 104 will be presented.
Up to approximately Week 104
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 12 weeks (Q12W) at Week 104
Ramy czasowe: Up to approximately Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 12 weeks (Q12W) at Week 104 will be presented.
Up to approximately Week 104
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 16 weeks (Q16W) at Week 104
Ramy czasowe: Up to approximately Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 16 weeks (Q16W) at Week 104 will be presented.
Up to approximately Week 104
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 1
Ramy czasowe: 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 ≥5 ETDRS letters from baseline to year 1 will be presented.
Baseline and 1 Year
Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 1
Ramy czasowe: 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.
Baseline and 1 Year
Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 1
Ramy czasowe: 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.
Baseline and 1 Year
Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 1
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Baseline and 1 Year
Time to gain ≥5 ETDRS Letters Over Time
Ramy czasowe: 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.
Up to approximately 2 years
Time to gain ≥10 ETDRS Letters at Week 52
Ramy czasowe: 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.
Up to approximately Week 52
Time to gain ≥15 ETDRS letters at Week 52
Ramy czasowe: 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
Ramy czasowe: 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.
Baseline and 2 Years
Proportion of Participants with BCVA Snellen Equivalent of 20/20 or Better at Year 1
Ramy czasowe: 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.
Up to approximately 1 year
Proportion of Participants with BCVA Snellen equivalent of 20/200 or Worse at Year 1
Ramy czasowe: 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.
Up to approximately 1 year
Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 1
Ramy czasowe: 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.
Up to approximately 1 year
Mean Change in BCVA from Baseline to Year 2
Ramy czasowe: Baseline and Year 2
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.
Baseline and Year 2
Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 2
Ramy czasowe: 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.
Up to approximately 2 years
Proportion of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Year 2
Ramy czasowe: 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
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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.
Baseline and 2 Years
Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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
Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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.
Baseline and 2 Years
Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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.
Baseline to 2 Years
Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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.
Baseline to 2 Years
Proportion of Participants who Lose ≥15 ETDRS Letters from Baseline to Year 2
Ramy czasowe: 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.
Baseline and 2 years
Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 48
Ramy czasowe: Baseline and Week 48
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.
Baseline and Week 48
Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at Week 104
Ramy czasowe: Baseline and Week 104
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.
Baseline and Week 104
Number of Participants who Experience a Systemic Adverse Events (AEs)
Ramy czasowe: 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.
Up to approximately 2 years
Number of Participants who Experience an Ocular Adverse Events (AEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Merck Sharp & Dohme LLC

Śledczy

  • Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

30 września 2026

Zakończenie podstawowe (Szacowany)

30 listopada 2028

Ukończenie studiów (Szacowany)

30 listopada 2029

Daty rejestracji na studia

Pierwszy przesłany

10 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lipca 2026

Pierwszy wysłany (Rzeczywisty)

15 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 8748-005
  • MK-8748-005 (Inny identyfikator: MSD)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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