CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

• Sponsor: AsclepiX Therapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04697758
• Collaborator: (none)
• Enrollment: 18
• Locations: 10
• Arms: 3
• Anticipated Duration (Months): 21.7
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema (DME)	Drug: AXT107 0.1 mg; Drug: AXT107 0.25 mg; Drug: AXT107 0.5 mg	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
• Actual Study Start Date: Dec 10, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose AXT107 0.1 mg/eye	Drug: AXT107 0.1 mg; Single intravitreal injection of AXT107 0.1 mg/eye
Experimental: Mid Dose AXT107 0.25 mg/eye	Drug: AXT107 0.25 mg; Single intravitreal injection of AXT107 0.25 mg/eye
Experimental: High Dose AXT107 0.5 mg/eye	Drug: AXT107 0.5 mg; Single intravitreal injection of AXT107 0.5 mg/eye

Outcome Measures

Primary Outcome Measures

1. Safety as Assessed by Incidence of Adverse Events (AEs) [Screening to Week 48]

   Incidence of ocular (study eye) and systemic AEs

Secondary Outcome Measures

1. Efficacy as Assessed by Central Retinal Thickness (CST) [Day 0 to Week 48]

   Mean change in CST assessed by spectral domain optical coherence tomography

2. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [Day 0 to Week 48]

   Mean change in BCVA

3. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [Day 0 to Week 48]

   Percentage of subjects improving ≥5, ≥10, and ≥15 letters in BCVA

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2

• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye

• Willing and able to comply with clinic visits and study-related procedures

• Provide signed inform consent

Exclusion Criteria:

• Any signs of high risk proliferative diabetic retinopathy in the study

• Previously-treated patients who are not responders to anti-VEGF

• Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye

Note: Other inclusion/exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AsclepiX Investigative Site	Gilbert	Arizona	United States	85053
2	AsclepiX Investigative Site	Los Angeles	California	United States	90211
3	AsclepiX Investigative Site	Saint Petersburg	Florida	United States	33711
4	AsclepiX Investigative Site	Boston	Massachusetts	United States	02114
5	AsclepiX Investigative Site	Reno	Nevada	United States	89502
6	AsclepiX Investigative Site	Eugene	Oregon	United States	97401
7	AsclepiX Investigative Site	Philadelphia	Pennsylvania	United States	19107
8	AsclepiX Investigative Site	Abilene	Texas	United States	79606
9	AsclepiX Investigative Site	McAllen	Texas	United States	78550
10	AsclepiX Investigative Site	The Woodlands	Texas	United States	77384

Sponsors and Collaborators

• AsclepiX Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AsclepiX Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04697758
• Other Study ID Numbers: AXT107-CS101
• First Posted: Jan 6, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AsclepiX Therapeutics, Inc.: AsclepiX; macular edema; DME; eye diseases; retinal diseases; AXT107; diabetes; duration of action; dose escalation; diabetic retinopathy; retinal degeneration
• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

No Results Posted as of Jul 20, 2022