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

NCT05301751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-15

Study results available
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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

Interventions

BIOLOGICAL

AG-73305

drug product solution

Sponsors & Collaborators

  • Lexitas Pharma Services, Inc.

    collaborator INDUSTRY

  • Allgenesis Biotherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2023-09-28
Completion
2023-12-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301751 on ClinicalTrials.gov