Phase 3
Completed N=466
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT01363440 ↗Enrolled (actual)
466
Serious AEs
47.1%
Results posted
Apr 2015
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) — .10; 12.3; 10.6 letters correctly read — p=<.0001
Summary
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) |
.10; 12.3; 10.6 | <.0001 sig |
| SECONDARY Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF |
30; 100; 88 | .0001 sig |
| SECONDARY Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF |
12; 64; 47 | <0.0001 sig |
| SECONDARY 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 - LOCF |
22; 52; 44 | <.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF |
-73.3; -184.1; -186.8 | <.0001 sig |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF |
3.7; 8.9; 8.1 | 0.0168 sig |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF |
4.9; 7.7; 6.5 | 0.1702 |
Eligibility Criteria
Inclusion Criteria
The following is an abbreviated list of inclusion criteria:
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- Decrease in vision determined to be primarily the result of DME in the study eye
- BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
The following is an abbreviated list of exclusion criteria:
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
- Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
- Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
- Active proliferative diabetic retinopathy (PDR) in the study eye
- Uncontrolled diabetes mellitus
- Only 1 functional eye even if that eye is otherwise eligible for the study
Data sourced from ClinicalTrials.gov (NCT01363440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.