NCT05301751

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Allgenesis Biotherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	AG-73305	drug product solution

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-09-28
• Completion: 2023-12-26
• First posted: 2022-03-31
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study