NCT05712720

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)

A Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants With Diabetic Macular Edema (DME)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Rezolute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema.

Detailed description

Diabetic macular edema (DME) is a common retinal microvascular complication in diabetic patients that can lead to progressive loss of visual acuity and ultimately to complete vision loss. DME is the main cause of vision loss in patients with Type 2 diabetes. There is a significant unmet medical need to develop better therapies of DME and diabetic retinopathy (DR). RZ402 is a potent and selective plasma kallikrein inhibitor (PKI), which is being developed as an oral therapy for the chronic treatment of DME and DR. This is a Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema (DME). A screening period of up to 4 weeks will evaluate eligibility. Once enrolled, patients will be randomized with a 1:1:1:1 ratio to receive RZ402 or placebo for up to 12 weeks. After completing dosing, the patient will enter into a 4 week follow up period.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Experimental: Group 1 - 50mg RZ402	RZ402 50 mg oral tablet, once daily for 3 months
DRUG	Experimental: Group 2 - 200mg RZ402	RZ402 200mg oral tablet, once daily for 3 months
DRUG	Experimental: Group 3 - 400mg RZ402	RZ402 400mg oral tablet, once daily for 3 months
OTHER	Placebo: Group 4 - Placebo	Placebo oral tablet, once daily for 3 months

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2023-02-03
• Last updated: 2025-10-03

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study