AG-73305 Single Ascending Dose Cohort Study in DME

• Sponsor: Allgenesis Biotherapeutics Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05301751
• Collaborator: Lexitas Pharma Services, Inc. (Industry)
• Enrollment: 25
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 16.2
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: AG-73305	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 9, 2022
• Anticipated Primary Completion Date: May 15, 2023
• Anticipated Study Completion Date: Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 A single intravitreal (IVT) dose of 0.5 mg AG-73305	Drug: AG-73305; AG-73305 Ophthalmic Solution
Experimental: Cohort 2 A single IVT dose of 1 mg AG-73305	Drug: AG-73305; AG-73305 Ophthalmic Solution
Experimental: Cohort 3 A single IVT dose of 2 mg AG-73305	Drug: AG-73305; AG-73305 Ophthalmic Solution
Experimental: Cohort 4 A single IVT dose of 3 mg AG-73305	Drug: AG-73305; AG-73305 Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

1. Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE) [Screening to 6 months]

Secondary Outcome Measures

1. Mean change from baseline in Best Corrected Visual Acuity (BCVA) [1 month]

2. Mean change from baseline in central subfield thickness (CST) [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Research Institute of Texas	Abilene	Texas	United States	79606
2	Strategic Clinical Research Group, LLC	Willow Park	Texas	United States	76087

Sponsors and Collaborators

• Allgenesis Biotherapeutics Inc.
• Lexitas Pharma Services, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allgenesis Biotherapeutics Inc.
• ClinicalTrials.gov Identifier: NCT05301751
• Other Study ID Numbers: P2-73305-001
• First Posted: Mar 31, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema

Study Results

No Results Posted as of Jul 5, 2022