Head to Head Study of Anti-VEGF Treatment.

This prospective, randomized, open label study enrolled patients with neovascular AMD who were naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the previous 3 months. Patients were randomized in two treatment arms for 3 months:

• Study arm 1: Three monthly injections of 0.5mg Ranibizumab
• Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff was blinded for treatment allocation.

Plasma VEGF concentration was measured by a blinded laboratory using Quantikine® ELISA kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA assay.

The study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to confirm the findings with justified sample size.

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Male or female patient ≥ 50 years of age.
• Subfoveal CNV secondary to nAMD.
• BCVA score must be between 73 and 24 letters as measured by ETDRS chart

Exclusion criteria

For both eyes

• Any active periocular or ocular infection or inflammation
• Uncontrolled glaucoma
• Neovascularization of the iris or neovascular glaucoma. For study eye
• Choroidal neovascularization of any other cause than wet AMD
• Ocular disorders present that may confound interpretation of study results,
• Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
• Structural damage within 0.5 disc diameter of the center of the macula
• Atrophy or fibrosis involving the center of the fovea.
• Inability of obtaining required lab report. Ocular medical history
• History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
• Any type of systemic disease or its treatment
• Any patients diagnosed with tumor.
• Stroke or myocardial infarction less than 3 months.
• Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
• Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
• Patients who have participated in other investigational drug study within 60 days.
• Pregnant or nursing (lactating) women.
• Inability to comply with study or follow-up procedures.