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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT00885794
Eligibility Criteria:
Inclusion Criteria:
* Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
* retinal thickening at or within 500µm from the center of the macula,
* hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
* a zone (\>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
* Second line treatment after ineffective laser treatment
* Men or women with diabetes mellitus
* Only one eye per patient
* Age \> 50 years
* HbA1c \< 8%
Exclusion Criteria:
* Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
* Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
* poor general condition
* woman of childbearing potential, current pregnancy or breastfeeding
* Patients who are unwilling to adhere to visit examination schedules
* Evidence of macular traction or taut posterior hyloid.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
51 Years
Study:
NCT00885794
Study Brief:
Protocol Section:
NCT00885794