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

ConditionDiabetic Macular Edema (DME)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEnnovaBio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent;

Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;

Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);

The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;

Disqualifiers

Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;

Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;

Study eye had previously undergone vitreoretinal surgery;

Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;

Trial design

Design model

Parallel

Treatments tested in this trial

  • ENN0403, low dose

    Drug

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

  • ENN0403, high dose

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ENN0403 low dose treatment armExperimental treatment 1 intervention
Group B: ENN0403 high dose treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Central Retinal Thickness (CRT) at week 12

Time frame
week 12

Secondary outcomes

1

Change from baseline in Best Corrected Visual Acuity (BCVA) at week 4, 8, and 12

Time frame
week 4, 8, 12
2

Change from baseline in CRT at week 4 and 8

Time frame
week 4, 8
3

Incidence of ocular and non-ocular TEAE and SAE

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EnnovaBio

Lead sponsor

Source ClinicalTrials.gov
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