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RECRUITING
NCT06708260
PHASE2

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

Sponsor: EnnovaBio

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-12-12

Completion Date

2026-02

Last Updated

2025-02-21

Healthy Volunteers

No

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.

Locations (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China