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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT03759860
Eligibility Criteria:
Inclusion Criteria:
1. Adults older than 19 years of age
2. Patients with Type-I or Type-II diabetes
3. Patients diagnosed with Clinically Significant Diabetic macular edema (CSME) based on the criteria of Early Treatment Diabetic Retinopathy Study (ETDRS).
* If thickened retina is within or lies on the circle with a radius of 500µm from the center of the fovea, or
* If the hard exudate is within or lies on the circle with a radius of 500 ㎛ and if the retina adjacent to it is thickened, or
* If there is a thickened retina larger than 1 disc area and if a part of it is over the circle with a radius of 1 disc diameter from the center of the macula.
4. Central Macular Thickness (CMT) of study eye is more than 300㎛ on OCT
5. Patients with BCVA of the study eye between 20/320 and 20/25.
6. Patients who have agreed to participate in this study and signed the consent form, and patients whose legally acceptable representative signed the consent form
Exclusion Criteria:
1. Patients with Ischemic DME that showed rupture in the Foveal Avascular Zone due to the obstruction of more than 30% of the capillary vessels in the central circle, as observed using fluorescein angiography
2. Patients with a history of focal steroid treatment in the study eye within 4 months
3. Patients with a history of anti-VEGF agent injection in the study eye within 3 months
4. Patients with rubeosis iridis, vitreous hemorrhage or tractional retinal detachment in the study eye
5. Patients with uncontrolled glaucoma in the study eye
6. Patients with active inflammation or infection in the study eye (in or around the eye)
7. Patients with disorders in the study eye that may confuse interpretation of the clinical trial results, cause severe visual loss, and require medical or surgical intervention during the study, based on the investigator's judgment (media opacity such as corneal opacity, cataract, and vitreous opacity, vitreous macular traction, uveitis, macular atrophy, macular degeneration, choroidal neovascularization, retinal vascular occlusion)
8. Persons with a history of treatment with anti-VEGF drugs within the past 6 months, or if they anticipate future use (e.g.: sorafenib (Nexavar®), sunitinib (Sutent®), bevacizumab (Avastin®))
9. Persons with confirmed allergy to fluorescein, indocyanine green or iodine
10. Patients with a clinically significant disorder such as uncontrolled renal failure that would make it difficult for them to participate in this study, based on the investigator's judgment
11. Pregnant or lactating woman
12. Patient not using contraception or with a possibility of pregnancy during the clinical trial period
13. Other persons deemed to be difficult to participate in this study, based on the investigator's judgment
14. Persons participating in a study other than observational or non-interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03759860
Study Brief:
Protocol Section:
NCT03759860