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

NCT05712720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-10-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Rezolute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-04-11
Completion
2024-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712720 on ClinicalTrials.gov