One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
- Sponsor
- University of Alexandria
- Study ID
- NCT03974425
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept Injection [Eylea] — DRUGintravitreal injection of Aflibercept in resistant DME.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2016
- Status verified
- Jun 2019
- Primary completion
- Apr 1, 2017
- Completion
- Apr 1, 2018
Study Design
- Enrollment
- 37 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Diabetic macular edema resistant to BevacizumabPatients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.
Primary Outcome Measure
central macular thickness after one year [ Time Frame: 12 months ]
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