Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema (SWITCH)

Bernardete Pessoa MD

Status: Completed

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]; Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Study type: Observational

Funder types: Other

Identifiers

NCT04018833

20190701245703984

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

40 participants in 2 patient groups

ranibizumab

Description:

Patients nonresponsive to bevacizumab that were switched to ranibizumab

Treatment:

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

aflibercept

Description:

Patients nonresponsive to bevacizumab that were switched to aflibercept

Treatment:

Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]