Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Key Inclusion Criteria:

1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately
severe to severe NPDR (DRSS levels 47 or 53), confirmed by the central reading center,
in whom PRP can be safely deferred for at least 6 months per the investigator

2. BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen
equivalent of 20/40 or better)

Key Exclusion Criteria:

1. Presence of DME threatening the center of the macula in the study eye

2. Evidence of retinal neovascularization on clinical examination or Fluorescein
Angiography (FA)

3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye

4. Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye

5. Any prior intraocular steroid injection in the study eye

6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional
retinal detachment visible at the screening assessments in the study eye