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A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME

NCT06708260 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-21

No results posted yet for this study

Summary

This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DRUG

ENN0403, low dose

ENN0403 capsules will be orally administered once a day for 12 weeks.

DRUG

ENN0403, high dose

ENN0403 capsules will be orally administered once a day for 12 weeks.

Sponsors & Collaborators

  • EnnovaBio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-12-31
Completion
2026-02-28

Countries

  • China

Study Locations

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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 NCT06708260 on ClinicalTrials.gov