A Phase III, multicenter, randomized, two-armed, double-blind, ‎parallel, active-controlled, non-inferiority clinical trial to compare efficacy ‎and safety of test-Aflibercept (CinnaGen Co, Iran) to the reference ‎Aflibercept product (Eylea®, Regeneron, USA) in patients with ‎Neovascular age-related macular degeneration.‎

Inclusion criteria:

male or female aged 55-80 years at the time of signing the informed consent form.‎ Patients with Primary active CNV subfoveal lesion secondary to AMD (with definite diagnosis of AMD ‎according to physician’s decision based on the results of ocular examination, or OCT)‎ the ETDRS-best-corrected visual acuity index with the score of 20/40 to 20/320 (or BCVA letter score of ‎‎73 to 25 in the study eye)‎ Willing, committed, and able to return for clinic visits and complete all study-related procedures Patients with the ability to read, understand and willing to sign the informed consent form for participation ‎in the study

Exclusion criteria:

Any prior ocular (in the study eye) or systemic anti-VEGF therapy, during the past 3 months, Photodynamic ‎Therapy (PDT) or surgery for neovascular AMD.‎ The need for receiving ocular anti-VEGF simultaneously in both eyes in the loading phase for the treatment of ‎neovascular AMD Scar, fibrosis, or extensive subretinal hemorrhage of more than 50% of the total lesion area in the study eye, ‎according to the physician's opinion based on clinical presentation or according to fundus photography.‎ The presence of scar, fibrosis, or atrophy in the central part of the fovea in the study eye‎ The presence of retinal pigment epithelial tears or rips involving the macular part of the study eye at the time of ‎entering the study The history of any vitreous hemorrhage within 4 weeks prior to the first visit of the study in the study eye‎ Presence of other causes of CNV in the study eye‎ Clinical or paraclinical diagnosis of PCV by physician’s diagnosis‎ The history or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease ‎affecting the retina, other than AMD in either eyes‎ Prior vitrectomy in the study eye‎ History of retinal detachment or treatment or surgery for retinal detachment in the study eye‎ Any history of a macular hole of stage 2 or above in the study eye‎ Any intraocular or periocular surgery within three months of the screening visit on the study eye except lid surgery, ‎which may not have taken place within one month of screening visit‎ Prior trabeculectomy or any other filtration surgery in the study eye‎ Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma ‎medication) in the study eye‎ Active intraocular inflammation in either eye‎ Active ocular or periocular infection in either eye or any ocular or periocular infection within the last two weeks prior ‎to screening visit in either eye‎ Any history of uveitis in either eye‎ Presence or history of scleromalacia in either eye‎ Aphakia or pseudophakia with the absence of posterior capsule (unless it occurred as a result of a yttrium ‎aluminum garnet [YAG] posterior capsulotomy) in the study eye Previous therapeutic radiation in the region of the study eye‎ History of corneal transplant or corneal dystrophy in the study eye‎ Any significant media opacities, including cataract, in the study eye that might interfere with visual acuity, ‎assessment of drug safety, or fundus photography‎ Patients with amblyopia. Patients with blindness in the fellow eye Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either ‎medical or surgical intervention during the study period Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the ‎risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which ‎otherwise may interfere with the injection procedure or with evaluation of efficacy or safety‎ History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving ‎reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might ‎affect the interpretation of the results of the study or render the patient at high risk for treatment complications‎ Participation as a patient in any clinical study within the 12 weeks prior to the screening visit‎ The use of long-acting steroids, either systemically or intraocularly, in the six months prior to screening visit‎ Any history of allergy to povidone iodine‎ Females who are pregnant, breastfeeding, planning to become pregnant during the study period, unwilling to ‎practice adequate contraception throughout the study and for at least 60 days following the last dose of study ‎medication ‏History of stroke, myocardial infarction or uncontrolled hypertension (blood pressure >160/100 despite receiving ‎medical treatment) for less than three months from the date of the Screening visit‎ Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, ‎pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders‎

Target sample size: 168