Phase 3
N=466
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01363440 ↗Enrolled (actual)
466
Serious AEs
47.1%
Results posted
Apr 2015
Primary outcome: 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 letters correctly read — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) (Drug); Macular Laser Photocoagulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Jan 2013
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 |
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.
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.