Clinical trial NCT04018833: Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Official title: Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Keywords: Diabetic Macular Edema
Bevacizumab
Ranibizumab
Aflibercept
BCVA
OCT
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients followed on the ocular diabetes consultation of Centro Hospitalar Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to intravitreal bevacizumab (1,25 MG/0.05 ML).

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anatomical change
timeFrame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
measure: Functional change
timeFrame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar do Porto
name: João Melo-Beirão, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirao JN. Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis. Clin Ophthalmol. 2021 Jan 22;15:253-260. doi: 10.2147/OPTH.S280644. eCollection 2021.