NCT03394573

Comparison of VA Guided Versus OCT Guided TER Using Aflibercept for Diabetic Macular Edema (AVOCT Study)

A Randomized, Study Investigating the Efficacy of Visual Acuity-based Versus Optical Coherence Tomography (OCT) -Based Treat and Extend Regimen Using Aflibercept in Patients With Diabetic Macular Edema

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of aflibercept (Eylea®) using two different treatment protocols in patients with vision loss from diabetic macular edema. While one group will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen, the other group will be treated according to a visual acuity (VA) guided 'treat and extend' protocol. The patients will be randomized into two treatment arms using an automated randomization algorithm.

Detailed description

For the study arm receiving the VA-guided treatment regimen, the following retreatment criteria will be applied: * if visual acuity remains stable (± 5 ETDRS letters) treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval. * if visual acuity decreases by more than 5 ETDRS letters treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval. For the study arm receiving the OCT-guided treatment regimen, the following retreatment criteria will be applied: * if SD-OCT examinations show 1) no SRF in any area of the OCT scan present and 2) no IRF, treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval. * if SD-OCT examinations show 1) any SRF present in any area of the OCT scan and/or 2) any IRF present, treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
OTHER	OCT guided treatment arm	Intravitreal injection of Aflibercept for DME OCT guided
OTHER	VA guided treatment arm	Intravitreal injection of Aflibercept for DME VA guided

Timeline

• Start date: 2017-09-16
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-01-09
• Last updated: 2021-03-18

Locations

1 site across 1 country: Switzerland