AG-73305 Single Ascending Dose Cohort Study in DME

Study Overview
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Brief Summary
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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).

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: AG-73305


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age or older at the screening visit Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association Presence of center-involving DME in the study eye with CST ≥ 325 μm 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: Uncontrolled diabetes mellitus, defined as hemoglobin A1c > 12.0% at Screening Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline Chronic renal disease Any active infection in either eye Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>A single intravitreal (IVT) dose of 0.5 mg AG-73305 | Drug: AG-73305<br>* AG-73305 Ophthalmic Solution<br>|
| Experimental: Cohort 2<br>A single IVT dose of 1 mg AG-73305 | Drug: AG-73305<br>* AG-73305 Ophthalmic Solution<br>|
| Experimental: Cohort 3<br>A single IVT dose of 2 mg AG-73305 | Drug: AG-73305<br>* AG-73305 Ophthalmic Solution<br>|
| Experimental: Cohort 4<br>A single IVT dose of 3 mg AG-73305 | Drug: AG-73305<br>* AG-73305 Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE) |  | Screening to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Best Corrected Visual Acuity (BCVA) |  | 1 month | 
| Mean change from baseline in central subfield thickness (CST) |  | 1 month |