A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
10 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1104
Phase
- Phase 3
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Administered by intravitreal injection (IVT)
Autres noms:
|
|
Expérimental: 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.
|
Administered by intravitreal injection (IVT)
Autres noms:
|
|
Comparateur actif: 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.
|
Administré par injection intravitréenne (IVT)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 septembre 2026
Achèvement primaire (Estimé)
30 novembre 2028
Achèvement de l'étude (Estimé)
30 novembre 2029
Dates d'inscription aux études
Première soumission
10 juillet 2026
Première soumission répondant aux critères de contrôle qualité
10 juillet 2026
Première publication (Réel)
15 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8748-005
- MK-8748-005 (Autre identifiant: MSD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .