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 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT01638858
Eligibility Criteria:
Inclusion Criteria:
1. diabetic macular edema with center involvement in at least one eye
2. patients with a central retinal thickness
3. patients with a BCVA of 78-24 EDTRS letters
4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
Exclusion Criteria:
1. history or evidence of severe cardiac disease
2. clinical or medical history uncontrolled hypertension or diabetes
3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
4. ventricular tachyarrhythmias requiring ongoing treatment
5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
6. clinically significant impaired renal or hepatic function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01638858
Study Brief:
Protocol Section:
NCT01638858