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Also known as EYE201, Tiespectus
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...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ocular Therapeutix Inc | OCUL | 1 | PHASE3 | OTX-TKI |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | Surabgene Lomparvovec |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| Jaeb Center for Health Research | RHHBY | 3 | PHASE3 | Faricimab, RO7663498 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
MK-8748 is an investigational small molecule being developed for diabetic retinopathy, including diabetic macular edema. It is not yet approved and remains in clinical development. Merck & Company, Inc. is studying it in adults with these retinal conditions, with the goal of offering a treatment option for diabetic eye disease.
MK-8748 targets Tie2, a receptor. Tie2 is involved in vascular stability and blood vessel function in the retina, and modulating it is the intended mechanism for addressing the vascular leakage and damage associated with diabetic retinopathy and diabetic macular edema. The drug is a small molecule.
Merck & Company, Inc., which trades under the ticker MRK, is developing MK-8748. The company is running the Phase 3 clinical program for the drug in diabetic retinopathy and diabetic macular edema.
MK-8748 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes two active Phase 3 trials, both currently recruiting, with a combined planned enrollment of 2,064 participants.
MK-8748 is being studied in two Phase 3 trials: NCT07705607, which is recruiting in the United States with 1,104 participants, and NCT07705555, which is recruiting in the United States and Australia with 960 participants. Both compare MK-8748 to aflibercept in adults with diabetic macular edema.
Both MK-8748 Phase 3 trials are randomized, double-blind, and active-controlled, comparing the drug to aflibercept in participants with diabetic macular edema. NCT07705607 and NCT07705555 enroll adults aged 18 years and older, and neither trial includes healthy volunteers.