A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)

Diabetic Macular Edema

Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

Change from baseline in BCVA as assessed by ETDRS letter score throughout the study at several pre-defined time points, Gain of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points, Loss of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points, Change from baseline in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT) throughout the study at several pre-defined time points, Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points, Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points during the trial, Incidence of ocular and non-ocular treatment-emergent adverse events, adverse events of special interest, and serious adverse events, Evaluation of ophthalmic parameters (intraocular pressure [IOP], biomicroscopy, and indirect ophthalmoscopy), Evaluation of routine safety parameters, Incidence and titer of anti-drug antibodies at several pre-defined time points during the study, Incidence of neutralizing antibodies at several pre-defined time points during the study, Evaluation of the systemic PK of free and bound aflibercept at several pre-defined time points during the study

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