Phase 3
N=381
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01783886 ↗Enrolled (actual)
381
Serious AEs
17.2%
Results posted
Apr 2016
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) — 13.7; 12.8; -0.2 Letters correctly read — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Biological); Macular Laser Photocoagulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2015
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) |
13.7; 12.8; -0.2 | <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 |
70.9; 62.7; 23.4 | <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 |
43.3; 36.5; 12.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF |
60.7; 62.3; 21.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF |
-238.7; -234.7; -109.3 | <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 |
6.65; 7.28; 0.04 | 0.0364 sig |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF |
3.93; 10.25; 0.04 | 0.2688 |
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 diabetic macular edema (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
- Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (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
- 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 (NCT01783886). 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.