Phase 3
N=406
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
Diabetes Mellitus · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01331681 ↗Enrolled (actual)
406
Serious AEs
—
Results posted
Sep 2014
Primary outcome: Primary: 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) — 10.5; 10.7; 1.2 Letters correctly read — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VEGF Trap-Eye (BAY86-5321) (Biological); Macular Laser Photocoagulation (Control) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
10.5; 10.7; 1.2 | <0.0001 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 |
54.4; 53.3; 25.8 | <0.0001 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 |
32.4; 33.3; 9.1 | <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 |
33.3; 27.7; 7.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF |
-195.0; -192.4; -66.2 | <0.0001 sig |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF |
5.73; 5.29; 3.54 | 0.2208 |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF |
0.94; 5.32; 2.26 | 0.5138 |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
- 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
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
- More than 2 previous macular laser treatments in the study eye
- Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
- Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
- Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
- Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
- Only 1 functional eye even if that eye is otherwise eligible for the study
Data sourced from ClinicalTrials.gov (NCT01331681). 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.