Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

10 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1104

Fase

  • Fase 3

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: MK-8748
Administered by intravitreal injection (IVT)
Altri nomi:
  • Tiespectus
  • EYE201
Sperimentale: 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.
Droga: MK-8748
Administered by intravitreal injection (IVT)
Altri nomi:
  • Tiespectus
  • EYE201
Comparatore attivo: 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.
Droga: Aflibercept
Somministrato mediante iniezione intravitreale (IVT)
Altri nomi:
  • Eylea

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Investigatori

  • Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

30 novembre 2028

Completamento dello studio (Stimato)

30 novembre 2029

Date di iscrizione allo studio

Primo inviato

10 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2026

Primo Inserito (Effettivo)

15 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 8748-005
  • MK-8748-005 (Altro identificatore: MSD)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Aflibercept

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Türkiye

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi