Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

Drug

Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Drug

Primary outcomes

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.

The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT <250 µm or >300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values.

Since patients with diabetic macular edema usually have CFT >300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT≥10%.
Functional 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.

Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale).

The higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of ≥5 EDTRS letters.

Sponsors and collaborators

Lead sponsor

Bernardete Pessoa MD

Other

Registry information

Acronym: SWITCH

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jul 15, 2019
Registry last updated: Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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