Diabetic Retinopathy Clinical Trial
— SWITCHOfficial title:
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Verified date | July 2019 |
Source | Centro Hospitalar do Porto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bernardete Pessoa MD |
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. |
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