Diabetic RetinopathyPhase 3NCT07705607
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
A Phase 3 study testing MK-8748 and Aflibercept in people with Diabetic Retinopathy and Macular Edema, run by Merck Sharp & Dohme LLC at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- MK-8748 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 19 sitesUnited States
- Study dates
- 25 Sep 2026to 30 Nov 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Palmetto Retina Center ( Site 0073)
Aiken, South Carolina, 29801
Study Coordinator, 803-931-0077
- Recruiting
Texas Retina ( Site 0051)
Arlington, Texas, 76012
Study Coordinator, 817-261-9625
- Recruiting
Charleston Neuroscience Institute ( Site 0090)
Beaufort, South Carolina, 29902
Study Coordinator, 843-763-4466
- Recruiting
Associated Vitreoretinal and Uveitis Consultants ( Site 0099)
Carmel, Indiana, 46032
Study Coordinator, 317-571-1501
- Recruiting
Charleston Neuroscience Institute ( Site 0076)
Charleston, South Carolina, 29414
Study Coordinator, 843-763-4466
- Recruiting
Texas Retina Associates ( Site 0055)
Fort Worth, Texas, 76104
Study Coordinator, 817-334-0882
- Recruiting
North Carolina Retina Associates ( Site 0122)
Greenville, North Carolina, 27834
Study Coordinator, 919-782-8091
- Recruiting
Cumberland Valley Retina Consultants ( Site 0003)
Hagerstown, Maryland, 21740
Study Coordinator, 301-665-1712
- Recruiting
Graystone Eye ( Site 0059)
Hickory, North Carolina, 28602
Study Coordinator, 828-304-6643
- Recruiting
Retina Consultants of Texas - Katy/Cinco Ranch ( Site 0100)
Katy, Texas, 77494
Study Coordinator, 713-524-3434
- Recruiting
Retina Consultants of South Carolina ( Site 0026)
Ladson, South Carolina, 29456
Study Coordinator, 843-763-4466
- Recruiting
Retina-Vitreous Surgeons of Central NY ( Site 0021)
Liverpool, New York, 13088
Study Coordinator, 315-445-8166
- Recruiting
Florida Retina Institute ( Site 0035)
Orlando, Florida, 32806
Study Coordinator, 407-849-9621
- Recruiting
Retina Center of Texas ( Site 0096)
Southlake, Texas, 76092
Study Coordinator, 817-865-6800
- Recruiting
Retina Vitreous Associates of Florida ( Site 0036)
St. Petersburg, Florida, 33711
Study Coordinator, 727-323-0077
- Recruiting
Retina Group of New England ( Site 0101)
Waterford, Connecticut, 06385
Study Coordinator, 860-444-1292
- Recruiting
Wolfe Eye Clinic ( Site 0044)
West Des Moines, Iowa, 50266
Study Coordinator, 515-223-8685
- Recruiting
Piedmont Retina Specialists ( Site 0049)
Winston-Salem, North Carolina, 27103
Study Coordinator, 336-397-9216
- Recruiting
Center for Retina and Macular Disease ( Site 0047)
Winter Haven, Florida, 33880
Study Coordinator, 863-297-5400
About this study
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)
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.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- MK-8748, Aflibercept
- Keywords
- Diabetic Macular Edema (DME)
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8748Drug
Also called EYE201, Tiespectus
Administered by intravitreal injection (IVT)
AfliberceptDrug
Also called Eylea
Administered by intravitreal injection (IVT)
| Study group | Role | What they receive |
|---|---|---|
| MK-8748 Low Dose | Experimental | Participants receive 5 initial administrations of MK-8748 low dose every 4 weeks (Q4W), then continue to receive MK-8748 low dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100. Receives: Drug: MK-8748 |
| MK-8748 High Dose | Experimental | Participants receive 5 initial administrations of MK-8748 high dose every 4 weeks (Q4W), then continue to receive MK-8748 high dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100. Receives: Drug: MK-8748 |
| Aflibercept 2 mg | Active comparator | Participants receive 5 initial administrations of aflibercept 2 mg every 4 weeks (Q4W), then continue to receive aflibercept 2mg every 8 weeks (Q8W) until week 100. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
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.
Measured: Baseline and 1 Year
Secondary outcomes (50)
Mean Change in Central Subfield Thickness (CST) from Baseline to 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.
Measured: Baseline and Week 52
Mean Change in CST from Baseline Over Time
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.
Measured: Up to approximately 2 years
Time to Absence of Diabetic Macular Edema (DME) at 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.
Measured: Up to approximately Week 52
Proportion of Participants with Absence of Intraretinal Fluid Over Time
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.
Measured: Up to approximately 2 years
Proportion of Participants with Absence of Subretinal Fluid Over Time
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.
Measured: Up to approximately 2 years
Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
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.
Measured: Up to approximately 2 years
Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at 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.
Measured: Up to approximately Week 24
Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to 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.
Measured: Baseline and Week 104
Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to 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.
Measured: Baseline and Week 104
Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to 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.
Measured: Baseline and Week 104
Proportion of Participants Without Retinal Fluid at the Foveal Center on OCT at 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.
Measured: Up to approximately Week 104
Mean change in Foveal Avascular Zone (FAZ) Area on Fluorescein Angiography (FA) from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants with Reduction in FAZ Area on FA from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants Without Retinal Fluid at the Foveal Center at 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.
Measured: Up to approximately Week 52
Mean Number of Intravitreal (IVT) Injections from Week 56 to Week 104
The mean number of intravitreal (IVT) Injections from week 56 to week 104 will be presented.
Measured: Up to approximately 48 Weeks
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 8 weeks (Q8W) at Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 8 weeks (Q8W) at Week 104 will be presented.
Measured: Up to approximately Week 104
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 12 weeks (Q12W) at Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 12 weeks (Q12W) at Week 104 will be presented.
Measured: Up to approximately Week 104
Proportion of Participants on a Personalized Treatment Interval (PTI) of every 16 weeks (Q16W) at Week 104
The proportion of participants on a personalized treatment interval (PTI) of every 16 weeks (Q16W) at Week 104 will be presented.
Measured: Up to approximately Week 104
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Proportion of participants who Lose ≥15 ETDRS Letters from Baseline to Year 1
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.
Measured: Baseline and 1 Year
Time to gain ≥5 ETDRS Letters Over Time
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.
Measured: Up to approximately 2 years
Time to gain ≥10 ETDRS Letters at 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.
Measured: Up to approximately Week 52
Time to gain ≥15 ETDRS letters at 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.
Measured: Up to approximately Week 52
Mean Change in BCVA (ETDRS letters) from Baseline Over Time
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.
Measured: Baseline and 2 Years
Proportion of Participants with BCVA Snellen Equivalent of 20/20 or Better at Year 1
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.
Measured: Up to approximately 1 year
Proportion of Participants with BCVA Snellen equivalent of 20/200 or Worse at Year 1
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.
Measured: Up to approximately 1 year
Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at Year 1
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.
Measured: Up to approximately 1 year
Mean Change in BCVA from Baseline to 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.
Measured: Baseline and Year 2
Proportion of Participants with BCVA Snellen Equivalent of 20/40 or Better at 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. 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.
Measured: Up to approximately 2 years
Proportion of Participants with BCVA Snellen Equivalent of 20/200 or Worse at 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. 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.
Measured: Up to approximately 2 years
Proportion of Participants who Gain ≥5 ETDRS Letters from Baseline to 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. The proportion of participants who gain ≥5 ETDRS Letters from baseline to year 2 will be presented.
Measured: Baseline and 2 Years
Proportion of Participants who Gain ≥10 ETDRS Letters from Baseline to 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. The proportion of participants who gain ≥10 ETDRS Letters from baseline to year 2 will be presented.
Measured: Baseline and 2 Years
Proportion of Participants who Gain ≥15 ETDRS Letters from Baseline to 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. The proportion of participants who gain ≥15 ETDRS letters from baseline to year 2 will be presented.
Measured: Baseline and 2 Years
Proportion of Participants who Lose ≥5 ETDRS Letters from Baseline to 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. The proportion of participants who lose ≥5 ETDRS Letters baseline to year 2 will be presented.
Measured: Baseline to 2 Years
Proportion of Participants who Lose ≥10 ETDRS Letters from Baseline to 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. The proportion of participants who lose ≥10 ETDRS letters from baseline to year 2 will be presented.
Measured: Baseline to 2 Years
Proportion of Participants who Lose ≥15 ETDRS Letters from Baseline to 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. The proportion of participants who lose ≥15 ETDRS Letters from baseline to year 2 will be presented.
Measured: Baseline and 2 years
Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at 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.
Measured: Baseline and Week 48
Change from Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Version Composite Score at 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.
Measured: Baseline and Week 104
Number of Participants who Experience a Systemic Adverse Events (AEs)
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.
Measured: Up to approximately 2 years
Number of Participants who Experience an Ocular Adverse Events (AEs)
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.
Measured: Up to approximately 2 years
Number of Participants who Discontinue Study Treatment Due to an AE
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.
Measured: Up to approximately 2 years
Number of Participants with Antidrug Antibodies (ADA) to MK-8748
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.
Measured: At designated time points (up to approximately 104 weeks)
Maximum Plasma Concentration (Cmax) of MK-8748
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.
Measured: At designated time points (up to approximately 104 weeks)
Plasma Trough Concentration (Ctrough) of MK-8748
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.
Measured: At designated time points (up to approximately 104 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start25 Sep 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705607
- Sponsor's protocol ID
- 8748-005
- Other IDs
- MK-8748-005, U1111-1340-0059, 2026-526787-20-00, jRCT2030260383
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf