Back to resultsAG-73305 Single Ascending Dose Cohort Study in DME
Primary Purpose
Diabetic Macular Edema
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AG-73305
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
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
Sites / Locations
- Retina Research Institute of TexasRecruiting
- Strategic Clinical Research Group, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
A single intravitreal (IVT) dose of 0.5 mg AG-73305
A single IVT dose of 1 mg AG-73305
A single IVT dose of 2 mg AG-73305
A single IVT dose of 3 mg AG-73305
Outcomes
Primary Outcome Measures
Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE)
Secondary Outcome Measures
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Mean change from baseline in central subfield thickness (CST)
Full Information
NCT ID
NCT05301751
First Posted
March 20, 2022
Last Updated
July 18, 2023
Sponsor
Allgenesis Biotherapeutics Inc.
Collaborators
Lexitas Pharma Services, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05301751
Brief Title
AG-73305 Single Ascending Dose Cohort Study in DME
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allgenesis Biotherapeutics Inc.
Collaborators
Lexitas Pharma Services, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
A single intravitreal (IVT) dose of 0.5 mg AG-73305
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
A single IVT dose of 1 mg AG-73305
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
A single IVT dose of 2 mg AG-73305
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
A single IVT dose of 3 mg AG-73305
Intervention Type
Drug
Intervention Name(s)
AG-73305
Intervention Description
AG-73305 Ophthalmic Solution
Primary Outcome Measure Information:
Title
Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE)
Time Frame
Screening to 6 months
Secondary Outcome Measure Information:
Title
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time Frame
1 month
Title
Mean change from baseline in central subfield thickness (CST)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Nguyen, PhD
Phone
+8862-87871232
Ext
105
Email
tan.nguyen@allgenesis.com
Facility Information:
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles L Clark, MD
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ross Lynds, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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AG-73305 Single Ascending Dose Cohort Study in DME
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