One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Aflibercept Injection [Eylea]

• Registration Number: NCT03974425
• Lead Sponsor: University of Alexandria

Brief Summary

Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.

Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-04-01
• Study Completion: 2018-04-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• diabetic patients, older than 18years,
• center-involving DME, central macular thickness (CMT) >300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
• The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.

Exclusion Criteria

• Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
• uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery >6 months prior to conversion).
• Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic macular edema resistant to Bevacizumab	Aflibercept Injection [Eylea]	Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.

Primary Outcome Measures

Name	Time	Method
central macular thickness after one year	12 months	Optical Coherence Tomography changes after 12 months.