A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
- Summary
- 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.
- Short title
- A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
- Official title
- 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)
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-11-30
- First posted
- 2026-07-15
- Registry last updated
- 2026-07-15
- Primary completion date
- 2028-11-30
- Start date
- 2026-09-30
- Participants
- 1,104
- Participant count basis
- Estimated
- Planned participants
- 1,104
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07705607
- ClinicalTrials.gov ID
- NCT07705607
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Timeframe: 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.
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Timeframe: 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.
Mean Change in CST from Baseline Over Time
Timeframe: 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.
Time to Absence of Diabetic Macular Edema (DME) at Week 52
Timeframe: 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.
Proportion of Participants with Absence of Intraretinal Fluid Over Time
Timeframe: 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.
Proportion of Participants with Absence of Subretinal Fluid Over Time
Timeframe: 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.
Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Timeframe: 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.
Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1
Timeframe: 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.
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1
Timeframe: 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.
Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24
Timeframe: 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.
Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to Week 104
Timeframe: 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.
Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to Week 104
Timeframe: 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.
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Week 104
Timeframe: 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.
Proportion of Participants Without Retinal Fluid at the Foveal Center on OCT at Week 104
Timeframe: 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.
Mean change in Foveal Avascular Zone (FAZ) Area on Fluorescein Angiography (FA) from Baseline to Year 1
Timeframe: 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.
Proportion of Participants with Reduction in FAZ Area on FA from Baseline to Year 1
Timeframe: 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.
Proportion of Participants Without Retinal Fluid at the Foveal Center at Week 52
Timeframe: 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.
Mean Number of Intravitreal (IVT) Injections from Week 56 to Week 104
Timeframe: Up to approximately 48 Weeks
The mean number of intravitreal (IVT) Injections from week 56 to week 104 will be presented.
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 8 weeks (Q8W) at Week 104
Timeframe: 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.
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 12 weeks (Q12W) at Week 104
Timeframe: 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.
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 16 weeks (Q16W) at Week 104
Timeframe: 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.
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 1
Timeframe: 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.
Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 1
Timeframe: 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.
Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 1
Timeframe: 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.
Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 1
Timeframe: 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.
Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 1
Timeframe: 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.
And 25 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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
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
- Related resource (www.merckclinicaltrials.com)
Other registry identifiers
- MK-8748-005
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Diabetic retinopathy Primary condition
- Macular retinal edema