Neovascular age-related macular degeneration and diabetic macular edema, retinal vein occlusion-related macular edema
Conditions
Interventions
Eylea (aflibercept) group:None
Zhuochuming (aflibercept biosimilar) group:None
Lucentis (ranibizumab) group:None
Rimmyrah (ranibizumab biosimilar) group:None
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, of either sex; 2.Clinically confirmed diagnosis of one of the approved indications for Zhuochuming® (aflibercept biosimilar), Rimmyrah® (ranibizumab biosimilar), Eylea® (aflibercept), or Lucentis® (ranibizumab), and the treating physician has determined, based on a thorough evaluation of the patient’s condition, that treatment with one of these agents is indicated; 3.Voluntary participation with written informed consent provided by the patient or their legally authorized representative (if the patient is unable to sign due to ocular disease, the legally authorized representative may sign on their behalf); 4.For the retrospective cohort, patients must have received at least one prior anti-VEGF therapy (with Zhuochuming, Rimmyrah, Eylea, or Lucentis) and have at least one follow-up visit with complete visual acuity and optical coherence tomography (OCT) data available; 5.For the prospective cohort, patients must be able to comply with the scheduled follow-up visits and all required data collection procedures.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to Zhuochuming® (aflibercept biosimilar), Rimmyrah® (ranibizumab biosimilar), Eylea® (aflibercept), Lucentis® (ranibizumab), or any of their excipients; 2.Presence of severe hepatic or renal insufficiency, cardiovascular or cerebrovascular diseases, or other systemic conditions that may affect the evaluation of the study; 3.Coexisting ocular diseases that may cause maculopathy or visual impairment, including acute angle-closure glaucoma, retinal detachment, macular hole, uveitis, optic neuropathy, and intraocular tumors; 4.Prior treatment with biological agents targeting the same molecular target (anti-VEGF) with occurrence of severe adverse reactions; 5.Pregnant or lactating women; 6.Patients with psychiatric disorders or cognitive impairment who are unable to comply with the study procedures; 7.Other conditions deemed by the investigator to be inappropriate for participation in this study; 8.Exclude patients who have previously participated in or are currently participating in drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core cost-effectiveness outcome;BCVA change from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central Retinal Thickness (CRT) change;Adverse event;Treatment compliance; | — |
Countries
China
Contacts
Public ContactSun Zuhua
Eye Hospital, Wenzhou Medical University
Outcome results
None listed