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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05712720 | Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) | PHASE2 | COMPLETED | 94 | — | — | Feb 6, 2023 | Apr 11, 2024 | Oct 3, 2025 | 32 | United States |
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo.
| Arm | Type | Description |
|---|---|---|
| Group 1 - 50 mg RZ402 | EXPERIMENTAL | RZ402 50mg oral tablet, once daily for 3 months |
| Group 2 - 200 mg RZ402 | EXPERIMENTAL | RZ402 200mg oral tablet, once daily for 3 months |
| Group 3 - 400 mg RZ402 | EXPERIMENTAL | RZ402 400mg oral tablet, once daily for 3 months |
| Group 4 - Placebo | PLACEBO_COMPARATOR | placebo oral tablet, once daily for 3 months |
| Name | Type | Description |
|---|---|---|
| Experimental: Group 1 - 50mg RZ402 | DRUG | RZ402 50 mg oral tablet, once daily for 3 months |
| Experimental: Group 2 - 200mg RZ402 | DRUG | RZ402 200mg oral tablet, once daily for 3 months |
| Experimental: Group 3 - 400mg RZ402 | DRUG | RZ402 400mg oral tablet, once daily for 3 months |
| Placebo: Group 4 - Placebo | OTHER | Placebo oral tablet, once daily for 3 months |
Inclusion Criteria: General Inclusion Criteria: 1. Confirmed diabetes mellitus Type 1 or Type 2 2. Stable glycemic control Study Eye Inclusion Criteria: 3. Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator. 4....
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | — | ADVM-022 |