Primary objective:
• To evaluate the change in aqueous humor vascular endothelial growth factor A (VEGF-A) levels after 2 months of initial treatment with 8 mg Aflibercept in treatment-naïve nAMD patients.
Secondary objectives:
• To assess the efficacy, safety, and biomarker changes of 8 mg Aflibercept using a modified fixed-interval dosing regimen over 12 months in treatment-naïve nAMD patients.
Patients who fully understand the content, procedures, and possible adverse events (AEs) of this study and are able to provide written informed consent;
Male or female patients aged ≥50 years at the time of signing the informed consent;
Women of childbearing potential (WOCBP) must agree to use dual contraception during the study and for 4 months after discontinuation of study treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom). Women who have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or menopause for more than 1 year are considered not of childbearing potential. Women of childbearing potential must have a negative pregnancy test at screening and must not become pregnant, breastfeed, lactate, or plan pregnancy, breastfeeding, or egg donation during the study and for 4 months after discontinuation of study treatment;
Male subjects whose partners are of childbearing potential must agree to use dual contraception during the study and for 4 months after the end of treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom), and must agree not to donate sperm during the study and for 4 months after the end of treatment.
Patients who have received other investigational treatments (including anti-VEGF, corticosteroids, laser photocoagulation treatments [panretinal photocoagulation or macular photocoagulation], and photodynamic therapy [PDT]) or approved nAMD drugs/therapies;
Patients with allergies or hypersensitivity reactions to any component/excipient of the investigational product;
Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg). Subjects may be treated with up to three known antihypertensive drugs to achieve adequate blood pressure control. This restriction applies to drugs that can be used for treating hypertension, even if the primary purpose of taking the drug for the subject is not blood pressure control. Any medication known to affect blood pressure must have a stable regimen for 12 weeks prior to screening;
History of other diseases, metabolic dysfunctions, abnormal physical examinations, or clinical laboratory abnormalities that reasonably suggest a contraindication to the investigational drug, may interfere with the interpretation of study results, or could place the patient at high risk for treatment-related complications;
Tianjin Medical University Eye Hospital
Lead sponsor
Hebei General Hospital
Collaborator
Shijiazhuang People's Hospital
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Shanxi Eye Hospital
Collaborator