Wet age-related macular degeneration
Conditions
Interventions
treatment group:Intravenous infusion of fraxinabecotide
Sponsors
Inner Mongolia Chaoyu Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age requirement Age >= 50 years old. 2. Diagnosis of nAMD The patient has been clinically diagnosed with neovascular age-related macular degeneration (nAMD), and this diagnosis is supported by any one or more of the following examination results: Optical coherence tomography (OCT) shows subretinal fluid leakage, cystoid edema or choroidal neovascularization (CNV). Fluorescein angiography (FA) shows leakage of choroidal neovascularization. Indocyanine green angiography (ICGA) shows abnormal vascular networks. 3. Vision requirement The best corrected visual acuity (BCVA) of the study eye on the ETDRS visual acuity chart is between 20/40 and 20/320 (approximately 73 to 25 letters in letter score). 4. Lesion characteristics The lesion is mainly choroidal neovascularization related to nAMD (classic type, occult type or mixed type). The lesion center involves the macular area. 5. Single eye study If both eyes of the patient meet the requirements, only one eye is selected as the study eye. 6. Previous treatment It can include patients who have received anti-VEGF treatment in the past, but they must meet the following conditions: At least 12 weeks have elapsed since the last anti-VEGF treatment. The condition is relatively stable, with no severe complications. Or newly diagnosed patients who have not received anti-VEGF treatment. 7. General health condition Blood pressure is well controlled (systolic pressure <= 160 mmHg, diastolic pressure <= 100 mmHg). There is no active severe infection or uncontrolled systemic diseases. 8. Compliance The patient can understand and sign the informed consent form, and is willing to receive treatment and follow-up as required by the study. 9. Other The medical history is clear, and there are no other diseases that can cause macular lesions or visual impairment (such as retinal vein occlusion, high myopic choroidal neovascularization, uveitis, etc.). The above inclusion criteria are designed to ensure the homogeneity of the research subjects, improve the reliability of the research data, and provide a scientific basis for the clinical evaluation of Fasudil in the treatment of nAMD.
Exclusion criteria
Exclusion criteria: 1. Any other ocular diseases or systemic diseases may affect the assessment of vision. 2. Patients who have received any anti-VEGF drugs or laser treatment within the past 3 months. 3. Patients who are allergic to fraxinib or any of its components. 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average value of the best corrected visual acuity (BCVA) change (compared with the baseline);the change in central retinal thickness (CRT); | — |
Secondary
| Measure | Time frame |
|---|---|
| The average value of the change in the best corrected visual acuity (BCVA) of the affected eye (compared with the baseline);The proportion of patients whose visual acuity improved by >=15 letters;Adverse events and serious adverse events that occurred during the treatment period;the change in central retinal thickness (CRT); | — |
Countries
China
Contacts
Public ContactGuisen Zhang
Inner Mongolia Chaoyu Eye Hospital
Outcome results
None listed