Retinal vein occlusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged >= 40 , regardless of gender; 2.Clinically diagnosed with CRVO or BRVO complicated by macular edema; 3.Best corrected visual acuity (BCVA) of the target eye: Snellen visual acuity chart 20/200 = 300 µm. 6.Non-contact tonometry (NCT) shows intraocular pressure < 22 mmHg;
Exclusion criteria
Exclusion criteria: Monocular vision, or best corrected visual acuity (BCVA) of the non-target eye examined by ETDRS visual acuity chart = -6D or the axial length measurement is >= 26mm. 11. The target eye has glaucoma (defined as an intraocular pressure >25 mmHg despite anti-glaucoma treatment), or severe glaucoma resulting in a cup-to-disc ratio >0.8 in the target eye, or the target eye has undergone glaucoma filtration surgery. 12. The elevated intraocular pressure of the target eye requires control with at least one medication. 13. The target eye has an ocular tumor. 14. Patients with uncontrolled diabetes mellitus (fasting blood glucose >=7.0 mmol/L or 2-hour postprandial blood glucose >=11.1 mmol/L), and/or complicated with diabetic retinopathy. 15. Subjects with a history of surgical operations within 1 month before enrollment, and/or with currently unhealed wounds, ulcers, fractures, etc. 16. Currently suffering from infectious diseases requiring oral, intramuscular, or intravenous administration of drugs. 17. Subjects with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before screening. 18. Subjects with poorly controlled hypertension (defined as blood pressure still >=150/95 mmHg despite antihypertensive medication treatment); 19. Subjects with a confirmed systemic autoimmune disorder (e.g., ankylosing spondylitis, systemic lupus erythematosus, Behçet's disease, etc.) or any uncontrolled clinical condition (e.g., HIV/AIDS, malignant tumor, active hepatitis, renal failure, severe systemic diseases of the mental, neurological, cardiovascular, respiratory, etc. systems, etc.). 20. Pregnant women (pregnancy in this trial is defined as a positive urine pregnancy test) and lactating women; 21. Subjects whom the investigator considers to have any factors that would prevent the target eye from achieving a visual acuity improvement of >=2 lines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokine (VEGF, IL-6, IL-8, VCAM, ICAM, MCP-1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Observe the safety within 6 months of intravitreal injection of anti-VEGF drugs or dexamethasone implants for macular edema secondary to retinal vein occlusion (RVO), especially the degree of lens opa; | — |
Countries
China
Contacts
Shenzhen Eye Hospital