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Also known as Experimental: Group 1- RZ402, Experimental: Group 2- 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....
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
RZ402 is being developed for the treatment of diabetic macular edema (DME), an eye condition involving fluid accumulation in the retina of people with diabetes. It is an investigational small molecule being studied in a Phase 2 clinical program. It has not been approved for commercial use.
RZ402 is being developed by Rezolute, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol RZLT. Rezolute is the sponsor of the clinical program evaluating RZ402 in diabetic macular edema.
RZ402 is in Phase 2 development. Its Phase 2 study in diabetic macular edema has been completed, and the drug remains investigational rather than approved. No active trials of RZ402 are currently listed.
RZ402 has been evaluated in the Phase 2 trial NCT05712720, titled Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME). The trial enrolled 94 participants in the United States, was randomized, double-blind, and placebo-controlled, and has completed.
The Phase 2 trial NCT05712720 enrolled adults 18 years of age and older of any sex, with diabetic macular edema. It did not enroll healthy volunteers. A total of 94 participants were randomized in the United States across the study's dose groups and placebo.