Phase
Condition
Blurred Vision
Vision Loss
Macular Degeneration
Treatment
Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion criteria for patients with nAMD
A diagnosis of nAMD
Patient aged ≥50 years
Patients for whom the decision to initiate treatment with intravitreal (IVT)aflibercept 8 mg according to a local product information was made as part ofroutine clinical practice
Signed informed patient consent before the start of data collection (according tothe requirements of the local authorities and laws)
Inclusion criteria for patients with DME
A diagnosis of DME
Patient aged ≥18 years (or country's legal age of adulthood if the legal age is >18years) with type 1 or type 2 diabetes mellitus
Patients for whom the decision to initiate treatment with IVT aflibercept 8 mgaccording to a local product information was made as part of routine clinicalpractice
Signed informed patient consent before the start of data collection (according tothe requirements of the local authorities and laws)
Exclusion
Exclusion Criteria:
Exclusion criteria for all patients with nAMD
Participation in an investigational program with interventions outside of clinicalroutine practice
Contraindications as listed in the local intravitreal aflibercept 8 mg local productinformation
Extra/periocular infection or inflammation in either eye at time of first injection
Patient receiving other intravitreal treatments other than aflibercept in the felloweye
Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8mg local product information Additional exclusion criteria for treatment-naïvepatients with nAMD
Any prior ocular treatment in the study eye or systemic treatment in nAMD Additionalexclusion criteria for pretreated patients with nAMD
Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
Prior treatment with intravitreal corticosteroid in the study eye within the last 3months
Fluocinolone implant in the study eye within the last 3 years
Dexamethasone implant in the study eye within the last 6 months
Any concurrent drug releasing implant in the study eye
Exclusion criteria for all patients with DME
Participation in an investigational program with interventions outside of clinicalroutine practice
Contraindications as listed in the intravitreal aflibercept 8 mg local productinformation
Extra/periocular infection or inflammation in either eye at time of first injection
Patient receiving other intravitreal treatments other than aflibercept in the felloweye
Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8mg local product information
Previous treatment of the study eye with laser in the last 90 days prior to firstIVT aflibercept 8 mg Additional exclusion criteria for treatment-naïve patients withDME
Any prior ocular treatment in the study eye or systemic treatment in DME Additionalexclusion criteria for pretreated patients with DME
Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
Prior treatment with intravitreal corticosteroid in the study eye within the last 3months
Fluocinolone implant in the study eye within the last 3 years
Dexamethasone implant in the study eye within the last 6 months
Any concurrent drug releasing implant in the study eye
Study Design
Connect with a study center
Many Locations
Multiple Locations,
AustraliaActive - Recruiting
Many Locations
Multiple Locations,
CanadaActive - Recruiting
Many Locations
Multiple Locations,
DenmarkActive - Recruiting
Many Locations
Multiple Locations,
FinlandActive - Recruiting
Many Locations
Multiple Locations,
FranceActive - Recruiting
Many Locations
Multiple Locations,
GermanyActive - Recruiting
Many Locations
Multiple Locations,
ItalyActive - Recruiting
Many Locations
Multiple Locations,
JapanActive - Recruiting
Many Locations
Multiple Locations,
Korea, Republic ofActive - Recruiting
Many Locations
Multiple Locations,
NetherlandsActive - Recruiting
Many Locations
Multiple Locations,
NorwaySite Not Available
Many Locations
Multiple Locations,
PortugalActive - Recruiting
Many Locations
Multiple Locations,
Saudi ArabiaActive - Recruiting
Many Locations
Multiple Locations,
SpainActive - Recruiting
Many Locations
Multiple Locations,
SwedenActive - Recruiting
Many Locations
Multiple Locations,
SwitzerlandActive - Recruiting
Many Locations
Multiple Locations,
United Arab EmiratesActive - Recruiting
Many Locations
Multiple Locations,
United KingdomActive - Recruiting
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