Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04018833
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04018833
Study Brief:
Protocol Section:
NCT04018833