AG-73305 Single Ascending Dose Cohort Study in DME

Allgenesis Biotherapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: AG-73305

Study type: Interventional

Funder types: Industry

Identifiers

NCT05301751

P2-73305-001

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

Cohort 1

Experimental group

Description:

A single intravitreal (IVT) dose of 0.5 mg AG-73305

Treatment:

Drug: AG-73305

Cohort 2

Experimental group

Description:

A single IVT dose of 1 mg AG-73305

Treatment:

Drug: AG-73305

Cohort 3

Experimental group

Description:

A single IVT dose of 2 mg AG-73305

Treatment:

Drug: AG-73305

Cohort 4

Experimental group

Description:

A single IVT dose of 4 mg AG-73305

Treatment:

Drug: AG-73305