AG-73305 Single Ascending Dose Cohort Study in DME

• Status: Not yet recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate 4 dosing cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allgenesis Biotherapeutics Inc.
• Collaborator: Lexitas Pharma Services, Inc.

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

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