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
Verified date | April 2024 |
Source | Allgenesis Biotherapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Allgenesis Biotherapeutics Inc. | Lexitas Pharma Services, Inc. |
United States,
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 |
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