To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
463
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Time frame: From baseline to Week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) at Week 52
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Time frame: From baseline to week 52
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Time frame: From baseline to week 52
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Time frame: From baseline to Week 100
Mean Change From Baseline in Central Retinal Thickness (CRT) at Week 100
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
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Unnamed facility
Graz, Styria, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Halifax, Nova Scotia, Canada
Unnamed facility
Mississauga, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Sherbrooke, Quebec, Canada
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Créteil, France
...and 54 more locations
Time frame: From baseline to Week 100
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Time frame: From baseline to Week 100
Number of Participants With Treatment-emergent Adverse Event (TEAE)
AEs that started after the first application of aflibercept under this protocol until 30 days after the last dose of study drug administration
Time frame: Up to Week 100