One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
|ClinicalTrials.gov Identifier: NCT03974425|
Recruitment Status : Completed
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Aflibercept Injection [Eylea]||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||April 1, 2018|
Diabetic macular edema resistant to Bevacizumab
Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.
Drug: Aflibercept Injection [Eylea]
intravitreal injection of Aflibercept in resistant DME.
- central macular thickness after one year [ Time Frame: 12 months ]Optical Coherence Tomography changes after 12 months.