Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study.

The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,

Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)

Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,

Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)

Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.

Leakage is the release of fluorescein dye from diseased retinal vessels.

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)

Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).

Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)

Concentrations of Free Aflibercept in Plasma by Time and Treatment Group

Pharmacokinetic analysis set (PKAS): All treated participants who received any amount of study drug and had at least 1 non-missing free or bound aflibercept measurement following the first dose of study drug as applicable. The PKAS is based on the actual treatment received (as treated) rather than as randomized.

Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)

Full Analysis Set (FAS) - for participants who had both baseline BCVA and week 48 BCVA; Only one study eye per participant was analyzed within the study

Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)

Full Analysis Set (FAS) - for participants who had both BCVA at 8 weeks post initial treatment and week 48 BCVA; Only one study eye per participant was analyzed within the study

Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

FAS: All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Here, Number of Participants Analyzed = Number of participants with week 60 data. Only one study eye per participant was analyzed within the study

Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported

ADA analysis set (AAS): All treated participants who received any amount of study drug and had at least 1 non-missing anti-aflibercept antibody result following the first dose of study drug. The AAS is based on the actual treatment received (as treated) rather than as randomized

A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.

Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)

A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.

Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)

TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.

Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.

Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.