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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05301751
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18 years of age or older at the screening visit
2. Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
3. Presence of center-involving DME in the study eye with CST ≥ 325 μm
4. Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients
5. Cohort 1: Previously treated with an anti-VEGF in the study eye; Cohorts 2, 3, and 4: Previously treated or treatment-naïve to the study eye
Exclusion Criteria:
1. Uncontrolled diabetes mellitus, defined as hemoglobin A1c \> 12.0% at Screening
2. Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline
3. Chronic renal disease
4. Any active infection in either eye
5. Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline
6. Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye
7. Uncontrolled intraocular pressure (IOP), defined as an IOP \> 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with \> 2 topical hypotensive medications
8. Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05301751
Study Brief:
Protocol Section:
NCT05301751