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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07457632
Eligibility Criteria:
Inclusion Criteria:
1. Age range 18-89 years
2. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200.
3. Written informed consent is provided.
4. Males and females
5. Routine laboratory study results CBC and Diff with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.
Exclusion Criteria:
1. History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months.
2. Eye having undergone YAG capsulotomy in the last 3 months.
3. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
4. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception if they are not trying to get pregnant.
5. Chronic infectious disease (e.g. HIV, HCV)
6. Positive urine β-hCG test day of visit or a serum-hCG test within 48 hours prior to the initiation of the study
7. Other ocular diseases or fundus diseases
8. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);
9. Use of cyclooxygenase-2 (COX-2) inhibitors for \< 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.
10. Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.
11. Any degree of hepatic or renal insufficiency that in the investigator's judgement would pose a safety risk with TUDCA or mQJDHW.
12. Subjects who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
13. Subjects who have a medical condition that, in the investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
14. Subjects with a current known infection or who are acutely ill.
15. Subjects with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).
16. Subjects with thyroid disorders unless euthyroid at screening.
17. Subjects with cancer not in remission.
18. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study.
19. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.
20. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
21. Use of any investigational drug/ nutraceuticals within 30 days prior to the baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT07457632
Study Brief:
Protocol Section:
NCT07457632