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Experimental: Group 1 - RZ402

Phase 2

Diabetic Macular Edema | Small molecule | Other |Rezolute, Inc.|Last Updated: Oct 3, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical trial landscape

Experimental: Group 1 - RZ402 · 1 trial · 1 indication

Phase 2 1
NCT05712720Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)Diabetic Macular Edema
COMPLETED94 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)
Diabetic Macular Edema
NCT0571272094
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Study Endpoints
Primary Endpoints
Safety Events
16 weeks

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Change in Central Subfield Thickness
12 weeks

Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo.

Secondary Endpoints
Change in BCVA
12 weeks
Change from baseline in Diabetic Retinopathy Severity Score (DRSS), compared to placebo.
12 weeks
Repeat-dose Cmax of RZ402
16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1 - 50 mg RZ402EXPERIMENTALRZ402 50mg oral tablet, once daily for 3 months
Group 2 - 200 mg RZ402EXPERIMENTALRZ402 200mg oral tablet, once daily for 3 months
Group 3 - 400 mg RZ402EXPERIMENTALRZ402 400mg oral tablet, once daily for 3 months
Group 4 - PlaceboPLACEBO_COMPARATORplacebo oral tablet, once daily for 3 months
Interventions
NameTypeDescription
Experimental: Group 1 - 50mg RZ402DRUGRZ402 50 mg oral tablet, once daily for 3 months
Experimental: Group 2 - 200mg RZ402DRUGRZ402 200mg oral tablet, once daily for 3 months
Experimental: Group 3 - 400mg RZ402DRUGRZ402 400mg oral tablet, once daily for 3 months
Placebo: Group 4 - PlaceboOTHERPlacebo oral tablet, once daily for 3 months
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites32

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....

Countries:United States
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Competitive Landscape -Diabetic Macular Edema 15 trials
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AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
AlvotechALVO1PHASE3AVT29, Eylea HD
Kiora Pharmaceuticals, Inc.KPRX1PHASE2KIO-104
REGENXBIO, Inc.RGNX1PHASE2RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept
Ocugen IncOCGN1PHASE1OCU200
Adverum Biotechnologies, Inc.ADVM1 - ADVM-022
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