Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Macular Edema Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ranibizumab

Patients nonresponsive to bevacizumab that were switched to ranibizumab

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

Intervention Type DRUG

aflibercept

Patients nonresponsive to bevacizumab that were switched to aflibercept

Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Intervention Type DRUG

Interventions

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Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

Intervention Type DRUG

Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No