Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04635800 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients | PHASE1 | COMPLETED | 21 | — | — | Dec 10, 2020 | May 24, 2022 | May 18, 2025 | 6 | United States, Puerto Rico |
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Best Correct Visual Acuity was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Intraocular pressure was measured per the sites' local standard operating procedures, via tonometry.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1; open-label, non-randomized, single administration |
| Cohort 2 | EXPERIMENTAL | Cohort 2; open-label, non-randomized, single administration |
| Cohort 3 | EXPERIMENTAL | Cohort 3, open-label; non-randomized, single administration |
| Cohort 4 | EXPERIMENTAL | Cohort 4, open-label, non-randomized, single administration |
| Name | Type | Description |
|---|---|---|
| MHU650 | DRUG | MHU650 powder for solution for injection |
Key Inclusion Criteria: * Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), or retinal vein occlusion (RVO). In the opinion of the investigator, the decrease in vision in the stud...
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