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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT02310295
Eligibility Criteria:
Inclusion Criteria:
1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
3. signed of inform Consent.
Exclusion Criteria:
1. HbA1c levels greater than 10%
2. thromboembolic event history (including myocardial infarction and stroke)
3. vitreo-macular traction on OCT
4. coagulation disorders
5. macular ischemia on fluorescein angiography examination
6. proliferative diabetic retinopathy that required treatment
7. eye surgery
8. history of ocular hypertension or glaucoma
9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
10. systemic corticosteroid therapy
11. any conditions that could affect the documentation
12. any previous treatment for diabetic macular edema.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02310295
Study Brief:
Protocol Section:
NCT02310295