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

Terminated

• Conditions: Diabetic Macular Edema
• Interventions: Other: OCT guided treatment arm; Other: VA guided treatment arm

• Registration Number: NCT03394573
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study Start: 2017-09-16
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-09
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCT guided treatment arm	OCT guided treatment arm	OCT guided aflibercept injection
VA guided treatment arm	VA guided treatment arm	VA guided aflibercept injection

Primary Outcome Measures

Name	Time	Method
Functional outcomes	24 months	Mean change in BCVA from baseline to week 104 (EOS)

Secondary Outcome Measures

Name	Time	Method
Number of visits	24 months	Number of visits per Treatment arm
Number of injections	24 months	Number of injections per Treatment arm

Trial Locations

Locations (1)

Inselspital Bern, Department of Ophthalmology; 🇨🇭 Bern, Switzerland