AG-73305 Single Ascending Dose Cohort Study in DME

Phase 2

Active, not recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: AG-73305

• Registration Number: NCT05301751
• Lead Sponsor: Allgenesis Biotherapeutics Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-31
• Study Start: 2022-06-09
• Primary Completion: 2024-02-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2	AG-73305	A single IVT dose of 1 mg AG-73305
Cohort 3	AG-73305	A single IVT dose of 2 mg AG-73305
Cohort 1	AG-73305	A single intravitreal (IVT) dose of 0.5 mg AG-73305
Cohort 4	AG-73305	A single IVT dose of 4 mg AG-73305

Primary Outcome Measures

Name	Time	Method
Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE)	Screening to 6 months

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Best Corrected Visual Acuity (BCVA)	1 month
Mean change from baseline in central subfield thickness (CST)	1 month

Trial Locations

Locations (6)

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Strategic Clinical Research Group, LLC; 🇺🇸 Willow Park, Texas, United States

Center of Macula and Retina Disease; 🇺🇸 Winter Haven, Florida, United States

Texas Retina Associates; 🇺🇸 Fort Worth, Texas, United States