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The trial is taking place at:
S

Strategic Clinical Research Group | Willow Park, TX

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AG-73305 Single Ascending Dose Cohort Study in DME

A

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)

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

Trial contacts and locations

6

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Central trial contact

Tan Nguyen, PhD

Data sourced from clinicaltrials.gov

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