Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

Sponsor
Bernardete Pessoa MD
Study ID
NCT04018833
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA). METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed. A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.

Key Dates

Start date
Jan 1, 2012
Status verified
Jul 2019
Primary completion
Jun 1, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
40 participants (actual)

Arms

  • Arm: ranibizumab
    Patients nonresponsive to bevacizumab that were switched to ranibizumab
  • Arm: aflibercept
    Patients nonresponsive to bevacizumab that were switched to aflibercept

Primary Outcome Measure

Anatomical change [ Time Frame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch. ]

Related Studies