Phase 3: testing MK-8748 for Diabetic Retinopathy
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.
Official registry: https://clinicaltrials.gov/study/NCT07705607 · Merck Sharp & Dohme LLC · enrollment listed as 1,104
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are MK-8748, or Aflibercept. The registry lists allocation as randomized. Researchers are looking for new ways to treat diabetic macular edema (DME).
They plan to enroll about 1,104 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: MK-8748, Aflibercept
Primary outcome (registry wording): Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- The main who can join 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 the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Public study contact (from the registry)
Toll Free Number
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
20 listed- South Coast Retina Center ( Site 0121) — Long Beach, California (recruiting)
- Retina Group of New England ( Site 0101) — Waterford, Connecticut (recruiting)
- Florida Retina Institute ( Site 0035) — Orlando, Florida (recruiting)
- Retina Vitreous Associates of Florida ( Site 0036) — St. Petersburg, Florida (recruiting)
- Center for Retina and Macular Disease ( Site 0047) — Winter Haven, Florida (recruiting)
- Associated Vitreoretinal and Uveitis Consultants ( Site 0099) — Carmel, Indiana (recruiting)
- Wolfe Eye Clinic ( Site 0044) — West Des Moines, Iowa (recruiting)
- Cumberland Valley Retina Consultants ( Site 0003) — Hagerstown, Maryland (recruiting)
- Retina-Vitreous Surgeons of Central NY ( Site 0021) — Liverpool, New York (recruiting)
- North Carolina Retina Associates ( Site 0122) — Greenville, North Carolina (recruiting)
- Graystone Eye ( Site 0059) — Hickory, North Carolina (recruiting)
- Piedmont Retina Specialists ( Site 0049) — Winston-Salem, North Carolina (recruiting)
FAQ about this NCT record
Is NCT07705607 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07705607?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07705607?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary