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

Primary Purpose

Diabetic Macular Edema (DME)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AXT107 0.1 mg
AXT107 0.25 mg
AXT107 0.5 mg
Sponsored by
AsclepiX Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema (DME) focused on measuring AsclepiX, macular edema, DME, eye diseases, retinal diseases, AXT107, diabetes, duration of action, dose escalation, diabetic retinopathy, retinal degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site
  • AsclepiX Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose

Mid Dose

High Dose

Arm Description

AXT107 0.1 mg/eye

AXT107 0.25 mg/eye

AXT107 0.5 mg/eye

Outcomes

Primary Outcome Measures

Safety as Assessed by Incidence of Adverse Events (AEs)
Incidence of ocular (study eye) and systemic AEs

Secondary Outcome Measures

Efficacy as Assessed by Central Retinal Thickness (CST)
Mean change in CST assessed by spectral domain optical coherence tomography
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Mean change in BCVA
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Percentage of subjects improving ≥5, ≥10, and ≥15 letters in BCVA

Full Information

First Posted
December 17, 2020
Last Updated
November 16, 2022
Sponsor
AsclepiX Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04697758
Brief Title
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
Acronym
CONGO
Official Title
Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AsclepiX Therapeutics, 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema (DME)
Keywords
AsclepiX, macular edema, DME, eye diseases, retinal diseases, AXT107, diabetes, duration of action, dose escalation, diabetic retinopathy, retinal degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
AXT107 0.1 mg/eye
Arm Title
Mid Dose
Arm Type
Experimental
Arm Description
AXT107 0.25 mg/eye
Arm Title
High Dose
Arm Type
Experimental
Arm Description
AXT107 0.5 mg/eye
Intervention Type
Drug
Intervention Name(s)
AXT107 0.1 mg
Intervention Description
Single intravitreal injection of AXT107 0.1 mg/eye
Intervention Type
Drug
Intervention Name(s)
AXT107 0.25 mg
Intervention Description
Single intravitreal injection of AXT107 0.25 mg/eye
Intervention Type
Drug
Intervention Name(s)
AXT107 0.5 mg
Intervention Description
Single intravitreal injection of AXT107 0.5 mg/eye
Primary Outcome Measure Information:
Title
Safety as Assessed by Incidence of Adverse Events (AEs)
Description
Incidence of ocular (study eye) and systemic AEs
Time Frame
Screening to Week 48
Secondary Outcome Measure Information:
Title
Efficacy as Assessed by Central Retinal Thickness (CST)
Description
Mean change in CST assessed by spectral domain optical coherence tomography
Time Frame
Day 0 to Week 48
Title
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Description
Mean change in BCVA
Time Frame
Day 0 to Week 48
Title
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Description
Percentage of subjects improving ≥5, ≥10, and ≥15 letters in BCVA
Time Frame
Day 0 to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AsclepiX Investigative Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
AsclepiX Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AsclepiX Investigative Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
AsclepiX Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
AsclepiX Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
AsclepiX Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
AsclepiX Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
AsclepiX Investigative Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
AsclepiX Investigative Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
AsclepiX Investigative Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

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Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

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