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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT01928550
Eligibility Criteria:
Inclusion Criteria:
a. Diagnosis of diabetes mellitus (type 1 or type 2).
Exclusion Criteria:
1. Inability to give informed consent.
2. Inability to maintain stable fixation for OCT imaging.
3. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
4. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
5. Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
6. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to treatment
7. Women who are pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography
8. Subject is expecting to move out of the area of the clinical center to an area and not willing to return for follow-up visits during the 6 months of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01928550
Study Brief:
Protocol Section:
NCT01928550