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:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT03143192
Eligibility Criteria:
Inclusion Criteria:
* Type I or Type II Diabetes Mellitus
* Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
* Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
* Patient's willingness and ability to attend the study visits
Exclusion Criteria:
* Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
* Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
* Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
* Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
* Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
* Significant renal disease requiring dialysis
* Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
* Presence of active ocular or periocular infection
* Presence of active intraocular inflammation
* Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03143192
Study Brief:
Protocol Section:
NCT03143192