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MK-8748 · 2 trials · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| MK-8748 | DRUG | Administered by intravitreal injection (IVT) |
| Aflibercept | DRUG | Administered by intravitreal injection (IVT) |
Inclusion Criteria: 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 edem...
MK-8748 is an investigational small molecule being developed for diabetic retinopathy, specifically for diabetic macular edema. It is currently in Phase 3 clinical trials comparing it to aflibercept in participants with diabetic macular edema.
MK-8748 targets Tie2, a receptor tyrosine kinase involved in vascular stability and angiogenesis. By modulating Tie2 activity, the drug aims to address the vascular pathology underlying diabetic retinopathy and macular edema.
MK-8748 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. The company is currently conducting Phase 3 trials for this investigational therapy.
MK-8748 is in Phase 3 clinical development. It is not yet approved by the FDA and remains investigational. Two Phase 3 trials are ongoing or planned, with one actively recruiting participants and the other not yet recruiting.
MK-8748 is being studied in two Phase 3 trials. NCT07705555 is recruiting 960 participants in the United States, and NCT07705607 plans to enroll 1104 participants. Both trials compare MK-8748 to aflibercept in patients with diabetic macular edema.
No, MK-8748 is not the same as aflibercept. MK-8748 is an investigational small molecule targeting Tie2, while aflibercept is an approved biologic that inhibits VEGF. In clinical trials, MK-8748 is being compared directly against aflibercept as an active control.