Macular Edema Secondary to Retinal Vein occlusion
Conditions
Interventions
Control Group:Intravitreal injection of aflibercept 2mg
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. Macular edema secondary to CRVO or BRVO (naive treatment) and visual impairment (lasting = 25 in the study eye at screening (~20/25 to 20/320 on the Snellen chart); 4. At the screening visit, the CST of SD-OCT (Heidelberg Spectralis or the same angiography system on other OCT instruments) was determined by the reading center >= 320 µm; 5. The investigators determined that the visual acuity of the study eye was decreased mainly due to macular edema secondary to RVO; 6. Other program-specific inclusion criteria that may apply.
Exclusion criteria
Exclusion criteria: 1. There is a history or evidence of any concurrent eye disease that the investigator believes may require drug or surgical intervention or vision changes during the study; 2. Active or suspected ocular or periocular infection or inflammation in either eye; 3. The study eye has previously received any approved or experimental treatment for macular edema secondary to RVO (eg, anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation); 4. Pregnant or lactating women or women planning to become pregnant during the study period; 5. Uncontrolled blood pressure, defined as systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg at rest; 6. Recent history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event (within 6 months before screening); 7. According to the judgment of the investigator, there is a medical history that may hinder the planned study visit, completion of the study or the safe administration of the investigational drug; 8. Other program-specific exclusion criteria that may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best corrected visual acuity (BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in best corrected visual acuity (BCVA) and central subfield thickness (CST) in both treatment groups;The average number of intravitreal injections during the study for both treatment groups.;Ocular and Systemic Adverse Event Rates at Weeks 24 and 52 in the Two Treatment Groups; | — |
Countries
China
Contacts
Public ContactLi Biwei
dMed Biopharmaceutical Co., Ltd
Outcome results
None listed