Aflibercept safety checked in indian DME patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female or male adult participant ≥18 years of age, with type 1 or 2 diabetes mellitus. * Participant must have diabetic macular edema (DME) secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of optical coherence tomography (OCT)) in the study eye. * Decrease in vision, determined to be primarily the result of DME in the study eye. * Retinal thickness of ≥300 µm in the study eye, as assessed by OCT. * Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study ( ETDRS) letter score of 73 to 24 (i.e., VA of 20/50 to 20/320) or equivalent in the study eye. * Participant for whom the decision to initiate treatment with Intravitreal (IVT) aflibercept has been made by the treating Investigator/Physician. * Willing and able to comply with clinic visits and study-related procedures. * Provide a signed Informed Consent Form (ICF) prior to any study procedures. Exclusion Criteria: * Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients). * History of vitreoretinal surgery and/or scleral buckling in the study eye. * Ocular conditions with a poorer prognosis in the fellow eye than in the study eye. * Received previous/ prior treatment as mentioned below: * Received anti-Vascular Endothelial Growth Factor (VEGF) drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc., including aflibercept) within the last 3 months of Day 1. * Received IVT dexamethasone or triamcinolone in the study eye within the last 3 months of Day 1. * Received intraocular or periocular corticosteroids in the study eye within the last 4 months of Day 1. * Had fluocinolone implant in the study eye within the last 3 years of Day 1. * Had dexamethasone implant in the study eye within the last 6 months of Day 1. * systemic anti-angiogenic agents within 6 months of Day 1. * Uncontrolled glaucoma in the study eye (patient who has had filtration surgery in the past, or likely to need filtration surgery in the future). * Only 1 functional eye even if that eye is otherwise eligible for the study. * Participated in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device. * Pregnant or breast-feeding women.