Diabetic Macular Edema
Conditions
Interventions
ENN0403 low dose treatment:ENN0403 capsules will be orally administered once a day for 12 weeks.
ENN0403 high dose treatment:ENN0403 capsules will be orally administered once a day for 12 weeks.
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent; 2. 18-80 years old, including boundary values, gender unlimited; 3. 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; 4. 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); 5. Diagnosis of Non-Proliferative Diabetic Retinopathy combined with Diabetic Macular Edema; 6. Sufficient clear eye media and sufficient pupil dilation are needed to obtain high quality retinal images to confirm the diagnosis; 7. BCVA letter score of <= 73 (Snellen 20/40) and = 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria,the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ; 8. The decrease of BCVA is mainly caused by Diabetic Macular Edema in the study eye; 9. Optical Coherence Tomography (OCT) foveal CRT at screening measuring =300 µm.(If both eyes of the subject meet the inclusion criteria, the study eyes will be determined by the investigator from a medical point of view); 10. All fertile female subjects and their male partners must use at least one highly effective contraceptive method from the signing of the informed consent throughout the study period until 3 months after the final dosing of the study, and all male subjects must consent to the use of condoms; 11. From the signing of the informed consent, throughout the study period until 3 months after the last dose of the study, all subjects have no plans of pregnancy, sperm donation or egg donation.
Exclusion criteria
Exclusion criteria: Study eye 1. Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss (such as moderate-to-severe cataract, active proliferative diabetic retinopathy, central retinal vascular obstruction, subretinal fibrosis or scarring in the macula, as determined by the investigator); 2. Study eye had glaucoma filtration surgery in the past or may have the surgery during the study; 3. Study eye had previously undergone vitreoretinal surgery; 4 Intraocular surgery (including cataract surgery), laser photocoagulation, yttrium aluminum garnet cystotomy, etc. may be performed within 3 months prior to baseline or during the study period; 5. Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline; 6. Aphakia (except intraocular lens); 7. Previous use of any steroid implants; Any eye 8. Any eye received intraocular injection of VEGF within 3 months prior to baseline; 9. History of idiopathic or autoimmune uveitis in any eye; 10. Intraocular or periocular infections or intraocular inflammation before baseline (including but not limited to infectious conjunctivitis, keratitis, scleritis, endophthalmitis, blepharitis contagiosa, uveitis, etc.); 11. Uncontrolled glaucoma in any eye (defined as IOP >= 25 mmHg after treatment with anti-glaucoma drugs); 12. Other eye conditions that investigator believe may affect recovery from macular edema; 13. History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment; 14. Poorly controlled hypertension (non-medicated subjects with seated systolic or diastolic blood pressure >= 160 mmHg or >= 90 mmHg; After receiving antihypertensive medication, subjects' sitting systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg)); 15. History of stroke, myocardial infarction, transient ischemic attack, or other thromboembolic diseases or related diseases; 16. Other clinical problems (such as cardiovascular, respiratory, urinary, psychiatric, nervous system diseases, and tumors) that the investigator assessed as uncontrollable; 17. Positive infectious disease test (Subjects who test positive for TB may still be enrolled in this study if there is no evidence of past or current active infection, as determined by the investigator); 18. Subjects have the following abnormal laboratory test indicators during screening that may affect the safety of subjects or the results of the study: - Hemoglobin level 2 ULN; - eGFR <= 60 ml/min/1.73m2 - Other abnormal laboratory indicators assessed by the investigator as unsuitable for inclusion 19. Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline, whichever is longer; 20. Subjects are investigators or their immediate family members, or subjects whose informed consent may have been improper; 21. Other factors considered inappropriate for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Central Retinal Thickness (CRT) at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Best Corrected Visual Acuity (BCVA) at week 4, 8, and 12;Change from baseline in CRT at week 4 and 8;Percentage of subjects with BCVA increases of at least 5, 10, and 15 letters from baseline at weeks 4, 8, and 12; Proportion of subjects with improved retinal morphopathologic status (e.g. bleeding, leakage, etc.) from baseline (investigator assessment) at week 4, 8, and 12, based on CFP, OCT, and FFA;Proportion of subjects receiving remedial treatment;Incidence of ocular and non-ocular TEAE and SAE;Incidence of laboratory measurements, vital signs, physical examination, 12-lead electrocardiogram abnormalities and changes from baseline;The concentration of ENN0403 in plasma and aqueous humor and plasma pharmacokinetic parameters ;AOC3 inhibition rate in plasma; | — |
Countries
China
Contacts
Public ContactXiaorongLi
Tianjin Medical University Eye Hospital
Outcome results
None listed