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

University of Alexandria

Status

Completed

Conditions

Diabetic Macular Edema

Treatments

Drug: Aflibercept Injection [Eylea]

Study type

Interventional

Funder types

Other

Identifiers

NCT03974425

31184

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.