18 and older, any sex, with Diabetes Mellitus or Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)Primary· Baseline up to Week 52
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
10.5
± 9.55
Intravitreal Aflibercept Injection 2Q8
10.7
± 9.32
Control
1.2
± 10.65
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCFSecondary· Baseline up to Week 52
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
54.4
Intravitreal Aflibercept Injection 2Q8
53.3
Control
25.8
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCFSecondary· Baseline up to Week 52
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
32.4
Intravitreal Aflibercept Injection 2Q8
33.3
Control
9.1
Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCFSecondary· Baseline up to Week 52
Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
33.3
Intravitreal Aflibercept Injection 2Q8
27.7
Control
7.5
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCFSecondary· Baseline up to Week 52
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
-195.0
± 146.59
Intravitreal Aflibercept Injection 2Q8
-192.4
± 149.89
Control
-66.2
± 138.99
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCFSecondary· Baseline up to Week 52
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
5.73
± 18.932
Intravitreal Aflibercept Injection 2Q8
5.29
± 19.058
Control
3.54
± 16.768
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCFSecondary· Baseline up to Week 52
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Group
Value
95% CI
Intravitreal Aflibercept Injection 2Q4
0.94
± 16.487
Intravitreal Aflibercept Injection 2Q8
5.32
± 18.475
Control
2.26
± 15.923
Adverse events — posted to ClinicalTrials.gov
Time frame: For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Intravitreal Aflibercept Injection 2Q4
Serious: 63
Deaths: —
Intravitreal Aflibercept Injection 2Q8
Serious: 60
Deaths: —
Macular Laser Photocoagulation (Control)
Serious: 51
Deaths: —
Serious adverse events (190 terms)
Reaction
System
Intravitreal Aflibercept I…
Intravitreal Aflibercept I…
Macular Laser Photocoagula…
Cataract
Eye disorders
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Myocardial infarction
Cardiac disorders
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Vitreous haemorrhage
Eye disorders
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Cerebrovascular accident
Nervous system disorders
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Acute myocardial infarction
Cardiac disorders
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Retinal neovascularisation
Eye disorders
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Pneumonia
Infections and infestations
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Humerus fracture
Injury, poisoning and procedural complications
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Cataract operation
Surgical and medical procedures
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Peripheral arterial occlusive disease
Vascular disorders
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Cardiac failure
Cardiac disorders
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Coronary artery disease
Cardiac disorders
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Coronary artery stenosis
Cardiac disorders
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Cataract subcapsular
Eye disorders
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Diabetic retinopathy
Eye disorders
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Retinal detachment
Eye disorders
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Ileus
Gastrointestinal disorders
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Cellulitis
Infections and infestations
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Diabetes mellitus
Metabolism and nutrition disorders
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Hyperglycaemia
Metabolism and nutrition disorders
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Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
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Osteoarthritis
Musculoskeletal and connective tissue disorders
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Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· NA
· recruiting
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· NA
· recruiting
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· NA
· recruiting
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· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 27 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01331681.