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

NCT03974425 | Completed

• 1 other identifier: 31184
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• central macular thickness after one year

  Optical Coherence Tomography changes after 12 months.

  12 months

Study Arms (1)

Diabetic macular edema resistant to Bevacizumab

OTHER

Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.

Drug: Aflibercept Injection [Eylea]

Interventions

Aflibercept Injection [Eylea] DRUG

intravitreal injection of Aflibercept in resistant DME.

Diabetic macular edema resistant to Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alexandria: lead

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 4, 2019
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share