High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

Subjects will be administered intravitreal aflibercept 8mg every 4 weeks, starting at week 0 for 8 weeks, then may be extended by 4-week intervals with no maximum between treatments with an end of study visit at week 96. At any visit, it will be determined if supplemental treatment is needed as determined by disease activity assessment until there is no regression of disease is noted and the extension intervals will begin again.

Inclusion criteria

• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Men or women > 18 years of age at the time of signing the Informed Consent Form
• Diagnosed with type 1 or type 2 diabetes mellitus
• BCVA ETDRS >/= 20/400 in the study eye
• Any Proliferative Diabetic Retinopathy as diagnosed via clinical examination and fluorescein angiography

Exclusion criteria

• Any known hypersensitivity to any of the components of aflibercept 8 mg injection
• Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used bye the site during the study
• Prior systemic anti-VEGF or IVT anti-VEGF treatment in the study eye within 3 months of enrollment. (i.e., 3-month (90 days) wash-out period for anti-VEGF allowed)
• Any intra- or periocular corticosteroid treatment in the study eye within 3 months (90 days) of baseline
• Any intraocular sustained-release treatment or implantable device in the study eye
• Any gene therapy in the study eye
• SD-OCT central subfield thickness measurement of > 320 µm, in the study eye
• Evidence of ocular infection, in the study eye, at time of screening
• IOP >/= 25 mmHg in the study eye
• Any intraocular inflammation/ infection in either eye within 12 weeks (84 days) of the screening visit
• History of vitreoretinal surgery in the study eye
• Any prior Panretinal laser photocoagulation (PRP) in the study eye
• Current vitreous hemorrhage obscuring clear view of the macula in the study eye (precluding baseline imaging and DRSS grading)
• Presence of any tractional retinal detachment (macular or peripheral) or pre-retinal fibrovascular proliferation (macular or peripheral) causing definite retinal traction or elevation (e.g. retinal tenting/peaking, tractional folds, or OCT-confirmed tractional distortion) in the study eye. Pre-retinal fibrovascular tissue without evidence of retinal traction or elevation (macular or peripheral) is permitted
• Cataract surgery in the study eye within 4 weeks prior to Screening/ Day 0
• Blood pressure > /=180/100 mmHg systolic/ diastolic, while seated
• Pregnant or breastfeeding women
• Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/ baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly, or total abstinence).

• Contraception is not required for men with documented vasectomy

• Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.