A Single Ascending Dose Cohort Study of AG-73305 in DME Patients

A Multicenter, Open-Labeled, Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of Intravitreal AG-73305 in Patients With Diabetic Macular Edema

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 diabetic macular edema (DME).

The objectives of this study were to evaluate the safety, tolerability, duration of effect, systemic pharmacokinetic and immunogenicity profiles of ascending doses of AG-73305 administered by intravitreal injection to patients with DME. Pharmacodynamic endpoints (e.g., best-corrected visual acuity [BCVA], spectral domain optical coherence tomography [SD-OCT], and optical coherence tomography angiography [OCT-A]) were evaluated over 6 months post-treatment. The maximum tolerated dose or the highest administered dose was evaluated for future studies.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Biological: AG-73305

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Winter Haven, Florida, United States, 33880
      • Center of Macula and Retina Disease
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 0.5 mg AG-73305 solution, single injection.	Biological: AG-73305; drug product solution
Experimental: Cohort 2; 1 mg AG-73305 solution, single injection.	Biological: AG-73305; drug product solution
Experimental: Cohort 3; 2 mg AG-73305 solution, single injection.	Biological: AG-73305; drug product solution
Experimental: Cohort 4; 4 mg AG-73305 solution, single injection.	Biological: AG-73305; drug product solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)	BCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.	1 month after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Central Subfield Thickness (CST)	SD-OCT imaging was performed at all visits utilizing Heidelberg Spectralis imaging equipment to assess changes over time in the structural details of the posterior segment of the eye. All images were graded by a central reading center.	1 month after dosing

Collaborators and Investigators

• Sponsor: Allgenesis Biotherapeutics Inc.
• Collaborators: Lexitas Pharma Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Allegenesis; AG-73305
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: P2-73305-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No