Status:
COMPLETED
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Lead Sponsor:
Bernardete Pessoa MD
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18-85 years
Brief Summary
PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macu...
Eligibility Criteria
Inclusion
- type 1 or type 2 diabetes mellitus patients
- older than 18 years
- with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).
- nonresponsive to bevacizumab, defined as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF\>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).
Exclusion
- additional ocular diseases that could significantly affect the visual acuity such as:
- significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema
- age-related macular degeneration
- retinal vascular occlusion
- central corneal opacity
- amblyopia
- advanced glaucoma
- optic neuropathy
- history of ocular trauma or surgery other than uncomplicated cataract extraction
- cataract surgery within 3 months before or after bevacizumab switch
- unable to provide written informed consent.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04018833
Start Date
January 1 2012
End Date
June 30 2016
Last Update
July 23 2019
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