Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME

Inclusion criteria

-Inclusion criteria - nAMD cohort

• Diagnosis of neovascular age-related macular degeneration in the eye under treatment.
• Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.
• The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.
• The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.
• Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.

Inclusion criteria

- DME cohort

• Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus.
• Patient aged ≥18 years at the time of the first aflibercept 8 mg injection.
• The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.
• The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.
• Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.

Exclusion criteria

applicable to both cohorts:

• Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.
• Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.
• Active extra-ocular or peri-ocular infection or active intraocular inflammation in either eye at the time of the first switch-related aflibercept 8 mg injection.
• Pre-existing ophthalmological condition in the eye under treatment (other than nAMD or DME) that, in the investigator's judgment, could materially affect the assessment of study outcomes - for example, advanced uncontrolled glaucoma, optic neuropathy or other retinal pathology.
• Concomitant use of any medicinal product whose interaction with intravitreal aflibercept 8 mg, as listed in the locally approved Summary of Product Characteristics, would compromise the assessment of treatment effect or patient safety.
• Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch/index date.
• Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch/index date.
• Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch/index date.
• Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch/index date.
• Any other concurrent drug-releasing intravitreal implant in the eye under treatment.
• Pregnancy at the time of the first switch-related aflibercept 8 mg injection.

Additional exclusion criterion - DME cohort only

• Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.