Diabetic Macular Edema
Conditions
Interventions
Control Group:Aflibercept 2 mg intravitreal injection
Sponsors
Kodiak Sciences China Inc
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent before joining the trial; 2. Treatment-naive patients diagnosed with diabetic macular edema with visual loss and central involvement (if present) within 9 months before screening; 3. BCVA ETDRS letter score = 25 in the study eye at screening (~20/25 to 20/320 on the Snellen chart); 4. The CST of SD-OCT (Heidelberg Spectralis or the same angiography system on other OCT instruments) is determined by the reading center >= 320 µm; 5. It is determined by the investigator that the vision loss of the study eye is mainly caused by DME; 6. Suffering from type 1 or type 2 diabetes and HbA1c <= 12%; 7. Other program-specific inclusion criteria that may apply.
Exclusion criteria
Exclusion criteria: 1. The study eye has active iris or angle neovascularization or neovascular glaucoma; 2. The study eye has the characteristics of proliferative diabetic retinopathy; 3. Within 3 months before screening, the study eye has a history of panretinal photocoagulation (PRP) laser surgery; 4. The study eye has traction retinal detachment; 5. The research eye has active retinal disease other than the research disease; 6. There is a history or evidence of any concurrent ocular disease (eg, vitreomacular traction, epimacular membrane) that may require medical or surgical intervention or affect macular edema or change vision during the study period in the investigator's opinion; 7. Active or suspected ocular or periocular infection or inflammation in either eye on day 1; 8. The study eye has previously received any approved or experimental DME therapy (eg, anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation); 9. Pregnant or lactating women or women planning to become pregnant during the study period; 10. Uncontrolled blood pressure, defined as systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg at rest; 11. Have a recent history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event (within 6 months before screening); 12. According to the judgment of the investigator, there is a medical history that may hinder the planned study visit, study completion or safe administration of the investigational drug; 13. Other program-specific exclusion criteria that may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of improvement in central zone thickness (CST);Improvement in Diabetic Retinopathy Severity Score;Average number of intravitreal injections during the study for both treatment groups;Ocular and systemic adverse event rates; | — |
Countries
China
Contacts
Public ContactLi Biwei
dMed Biopharmaceutical Co., Ltd
Outcome results
None listed