Retinal vein occlusion,RVO
Conditions
Interventions
Cohort 1: Prospective Cohort:None
Cohort 2: Retrospective Cohort:None
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Must be willing to voluntarily sign the informed consent form (ICF). 2.Must be willing and able to comply with the treatment and follow-up procedures required by the study. 3.Age >=18 years, of any gender. 4.The study eye is diagnosed with Retinal Vein Occlusion (RVO) according to the Expert Consensus on the Clinical Diagnosis and Treatment Pathway for Retinal Vein Occlusion in China. The study eye must have macular edema, defined as the presence of macular edema on Optical Coherence Tomography (OCT) with a central retinal thickness (CRT) >=300 µm. 5.Best Corrected Visual Acuity (BCVA) score is greater than 24 and less than 79 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or contraindications to the active substance or any of the excipients of the investigational drug. 2.The study eye has received any treatment, including anti-VEGF drugs or corticosteroids, within 12 weeks prior to the screening period. 3.Has received systemic anti-VEGF therapy within 6 months prior to the screening visit. 4.Any condition that, in the judgment of the investigator, would make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCVA at 3 months: The change in Best Corrected Visual Acuity (BCVA) in the study eye from baseline to month 3. (Results from all testing methods will be converted to approximate Early T; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BCVA at 12 months: The change in BCVA in the study eye from baseline to month 12.;Mean change in CRT at 12 months: The change in Central Retinal Thickness (CRT) in the study eye from baseline to month 12.;Medical costs: The patient's total expenses for the investigational drug from enrollment to the end of treatment (including registration fees, drug costs, injection fees, and examination fees).;Travel costs: The patient's total round-trip expenses for traveling to the hospital for follow-up or treatment from enrollment to the end of treatment.;Time costs: The total time required for the patient to travel to the hospital for follow-up or treatment from enrollment to the end of treatment (including travel time, examination time, and consultat;Incidence rate of adverse reactions;Total number of injections: The total number of investigational drug injections administered to the study eye from enrollment to the end of treatment.;Total number of follow-up visits: The total number of follow-up visits the patient attended from enrollment to the end of treatment (including visits for examination only and visits for treatment).;Quality of life: The change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score at month 12.; | — |
Countries
China
Contacts
Public ContactWang Lifei
Hebei Eye Hospital
Outcome results
None listed