Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

Prior treatment

• Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
• Treatment with ocriplasmin (JETREA®) in the study eye at any time
  • NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Other illness

• Evidence of macular edema due to any cause other than diabetes mellitus in either eye

Lab values

• IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye

Other

• Active proliferative diabetic retinopathy in the study eye

• Diabetic macular edema (DME) with central involvement in the study eye
• Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
• Willing and able to comply with clinic visits and study-related procedures
• Provide informed consent signed by study participant or legally acceptable representative
  • Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.