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

NCT05301751 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: P2-73305-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Diabetic Macular Edema

Keywords

Allegenesis; Diabetic Macular Edema; AG-73305

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change From Baseline in Central Subfield Thickness (CST)

  1 month after dosing

Study Arms (4)

Cohort 1

EXPERIMENTAL

0.5 mg AG-73305 solution, single injection.

Biological: AG-73305

Cohort 2

EXPERIMENTAL

1 mg AG-73305 solution, single injection.

Biological: AG-73305

Cohort 3

EXPERIMENTAL

2 mg AG-73305 solution, single injection.

Biological: AG-73305

Cohort 4

EXPERIMENTAL

4 mg AG-73305 solution, single injection.

Biological: AG-73305

Interventions

AG-73305 BIOLOGICAL

drug product solution

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allgenesis Biotherapeutics Inc.: lead
• Lexitas Pharma Services, Inc.: collaborator

Study Sites (6)

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Center of Macula and Retina Disease

Winter Haven, Florida, 33880, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Limitations and Caveats

Study was designed to assess safety, and efficacy endpoints were not statistically powered. Results should be interpreted with caution.

Results Point of Contact

• Title: Tan Nguyen, Vice President of R&D
• Organization: Allgenesis Biotherapeutics Inc.

tan.nguyen@allgenesis.com

+886-2-87871232

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 31, 2022
• Study Start: May 19, 2022
• Primary Completion: September 28, 2023
• Study Completion: December 26, 2023
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)