Phase 4
Completed N=560
Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
Source: ClinicalTrials.gov NCT02581995 ↗Enrolled (actual)
560
Serious AEs
11.8%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline to Week 52 in NEI VFQ-25 Total Score — 6.106 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 52 in NEI VFQ-25 Total Score |
6.106 | — |
| SECONDARY Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale |
11.370 | — |
| SECONDARY Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale |
7.331 | — |
| SECONDARY Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score]) |
10.0 | — |
| SECONDARY Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT) |
-175.38 | — |
| SECONDARY Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP) |
0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 or 2 diabetes mellitus
- Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
- Decrease in vision determined to be primarily the result of DME in the study eye
- BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion Criteria
- Pregnancy and lactation
- Mismatch with inclusion criteria
Data sourced from ClinicalTrials.gov (NCT02581995). 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.