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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04418427
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Type 1 or Type 2 diabetes mellitus
* Willing and able to provide informed consent
* Vision impairment due to center involving diabetic macular edema
Exclusion Criteria:
* Uncontrolled diabetes defined as HbA1C \>10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months.
* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
* Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
* Known severe renal impairment
* High risk Proliferative Diabetic Retinopathy
* History of retinal disease in the study eye other than diabetic retinopathy
* History of retinal detachment (with or without repair) in the study eye
* History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
* Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
* Current or planned pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04418427
Study Brief:
Protocol Section:
NCT04418427