A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)

Conditions

• Diabetic Retinopathy
• Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MK-8748 — DRUG
  Administered by intravitreal injection (IVT)
• Aflibercept — DRUG
  Administered by intravitreal injection (IVT)

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Aug 27, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2029

Study Design

Enrollment

960 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1 [ Time Frame: Baseline and 1 Year ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (3)

Find similar trials in Glendale, CA

Related Studies

• Village-Integrated Eye Worker Trial II
  Recruiting · University of California, San Francisco · San Francisco, California
• A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
  PHASE2 · Recruiting · Vantage Biosciences Ltd · Beverly Hills, California
• Strategies for Improving Linkage-to-Care After Eye Disease Screening
  Recruiting · University of California, San Francisco · San Francisco, California
• A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
  PHASE2 · Recruiting · Boehringer Ingelheim · Phoenix, Arizona