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/NCT07705555 · Merck Sharp & Dohme LLC · enrollment listed as 960
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 960 people at 35 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
35 listed- Associated Retina Consultants, Ltd ( Site 0084) — Gilbert, Arizona (recruiting)
- Global Research Management ( Site 0066) — Glendale, California (recruiting)
- Retinal Consultants Medical Group ( Site 0013) — Sacramento, California (recruiting)
- Retina Specialists of Colorado ( Site 0068) — Denver, Colorado (recruiting)
- Retina Consultants ( Site 0065) — Manchester, Connecticut (recruiting)
- Vitreo Retinal Associates ( Site 0042) — Gainesville, Florida (recruiting)
- Retina Care Specialists ( Site 0095) — Palm Beach Gardens, Florida (recruiting)
- Retina Vitreous Associates of Florida ( Site 0034) — Tampa, Florida (recruiting)
- Florida Retina Institute ( Site 0105) — Wildwood, Florida (recruiting)
- Midwest Eye Institute ( Site 0113) — Carmel, Indiana (recruiting)
- Retina Associates LLC ( Site 0024) — Lenexa, Kansas (recruiting)
- Mid Atlantic Retina ( Site 0062) — Hagerstown, Maryland (recruiting)
+ 6 sites outside the US on the same record
FAQ about this NCT record
Is NCT07705555 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 NCT07705555?
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 NCT07705555?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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