Status:
COMPLETED
A Single Ascending Dose Cohort Study of AG-73305 in DME Patients
Lead Sponsor:
Allgenesis Biotherapeutics Inc.
Collaborating Sponsors:
Lexitas Pharma Services, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate the safety and efficacy of 4 dose cohorts of AG-73305 administered by intravitreal injection in patients with dia...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or older at the screening visit
- Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
- Presence of center-involving DME in the study eye with CST ≥ 325 μm
- 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
- 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
- Uncontrolled diabetes mellitus, defined as hemoglobin A1c \> 12.0% at Screening
- Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline
- Chronic renal disease
- Any active infection in either eye
- Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline
- Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye
- 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
- Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05301751
Start Date
May 19 2022
End Date
December 26 2023
Last Update
October 15 2025
Active Locations (6)
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1
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
2
Center of Macula and Retina Disease
Winter Haven, Florida, United States, 33880
3
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
4
Texas Retina Associates
Fort Worth, Texas, United States, 76104