AG-73305 Single Ascending Dose Cohort Study in DME

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05301751
• Other study ID #: P2-73305-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 9, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Allgenesis Biotherapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate 4 dosing cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: October 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• AG-73305
AG-73305 Ophthalmic Solution

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Texas Retina Associates	Fort Worth	Texas
United States	Valley Retina Institute	McAllen	Texas
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Center of Macula and Retina Disease	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Allgenesis Biotherapeutics Inc.	Lexitas Pharma Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE)		Screening to 6 months
Secondary	Mean change from baseline in Best Corrected Visual Acuity (BCVA)		1 month
Secondary	Mean change from baseline in central subfield thickness (CST)		1 month