Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Experimental: Group 1 - 50mg RZ402, Experimental: Group 1- RZ402, Experimental: Group 2 - 200mg RZ402, Experimental: Group 2- RZ402, Experimental: Group 3 - 400mg RZ402, Experimental: Group 3- RZ402
RZ402 · 1 trial · 1 indication
Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo. Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
| 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....
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