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

NCT06708260 | Recruiting Phase 2

• 1 other identifier: ENN0403-P2-CN-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

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

  week 12

Secondary Outcomes (3)

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

  week 4, 8, 12

• Change from baseline in CRT at week 4 and 8

  week 4, 8

• Incidence of ocular and non-ocular TEAE and SAE

  12 weeks

Study Arms (2)

ENN0403 low dose treatment arm

EXPERIMENTAL

Drug: ENN0403, low dose

ENN0403 high dose treatment arm

EXPERIMENTAL

Drug: ENN0403, high dose

Interventions

ENN0403, low dose DRUG

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

ENN0403 low dose treatment arm

ENN0403, high dose DRUG

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

ENN0403 high dose treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.

You may not qualify if:

• 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;
• Any eye received intraocular injection of VEGF within 3 months prior to baseline;
• History of idiopathic or autoimmune uveitis in any eye;
• Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)
• History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;
• Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);

Sponsors & Collaborators

• EnnovaBio: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

Central Study Contacts

Lei Huang

CONTACT

021-50821573; lei.huang@ennovabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2024-11

Locations

CN (1)