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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974425
• Other study ID #: 31184
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: June 2019
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Aflibercept Injection [Eylea]
intravitreal injection of Aflibercept in resistant DME.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central macular thickness after one year	Optical Coherence Tomography changes after 12 months.	12 months