Sudden or gradual decrease in central visual acuity
Conditions
Interventions
Experimental Group:Aflibercept 8mg treatment
Sponsors
The Second Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Naïve nAMD patients aged >=50 years; 2. Subfoveal active choroidal neovascularization (CNV); 3.Presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) observable on OCT in the subfoveal region; 4.Visual acuity decline due to nAMD, with best-corrected visual acuity (BCVA) of 24–78 letters (equivalent to Snellen visual acuity of 20/32 to 20/320);
Exclusion criteria
Exclusion criteria: 1.Diabetic retinopathy, diabetic macular edema, or non-nAMD retinal vascular disease in the contralateral eye; 2.Retinal pigment epithelium (RPE) tear in the study eye, or subfoveal scar, fibrosis, or atrophic lesions; 3.Extraocular/periorbital infection or inflammation in any eye at screening/randomization; 4.Uncontrolled blood pressure (systolic >160 mmHg or diastolic >95 mmHg); 5.Without sufficiently clear ocular media and adequate pupillary dilation, high-quality retinal images for definitive diagnosis cannot be obtained. 6.Patients who have received other investigational therapies (including anti-VEGF agents, glucocorticoids, laser photocoagulation (panretinal photocoagulation or macular photocoagulation), and photodynamic therapy (PDT)), or approved drugs/therapies for nAMD. 7.Patients with a history of hypersensitivity or allergy to any component/excipient in the investigational product. 8.Patients with a history of other diseases, metabolic dysfunction, or abnormal physical findings, for which there is reasonable basis to suspect a condition that would contraindicate the use of the investigational product, interfere with the interpretation of study results, or place the patient at high risk of treatment-related complications. 9.Patients with a positive pregnancy test during the screening period. 10.Any condition that, in the investigator’s judgment, may affect the patient’s ability to provide informed consent, comply with the study protocol, complete the trial in accordance with study procedures, or may compromise trial results or the patient’s safety if the patient participates in the study. 11.Fluorescein Angiography (FA) / Fundus Photography (FP) demonstrates: a a. Total lesion area (including hemorrhage, scarring, and neovascularization) greater than 12 disc areas (30.5 mm²); b b. Fibrosis or atrophy > 50% of the total lesion area, and/or involving the fovea. 12.Any concurrent intraocular disorder that, in the investigator’s judgment, may reduce visual improvement or require medical or surgical intervention during the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity, BCVA; | — |
Countries
China
Contacts
Public ContactJun Xiao
The Second Hospital of Jilin University
Outcome results
None listed