Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— SWITCH  

Official title:

Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018833
• Other study ID #: 20190701245703984
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: July 2019
• Source: Centro Hospitalar do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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, de?ned 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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

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

• Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bernardete Pessoa MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical change	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%.	Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Primary	Functional change	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.	Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.