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Diabetic Macular Edema (DME)Phase 1/2CONGONCT04697758

Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

A Phase 1/2 study testing AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg in people with Diabetic Macular Edema (DME), run by AsclepiX Therapeutics, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
10 sitesUnited States
Study dates
10 Dec 2020to 1 Oct 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • AsclepiX Investigative Site

    Abilene, Texas, 79606

  • AsclepiX Investigative Site

    Boston, Massachusetts, 02114

  • AsclepiX Investigative Site

    Eugene, Oregon, 97401

  • AsclepiX Investigative Site

    Gilbert, Arizona, 85053

  • AsclepiX Investigative Site

    Los Angeles, California, 90211

  • AsclepiX Investigative Site

    McAllen, Texas, 78550

  • AsclepiX Investigative Site

    Philadelphia, Pennsylvania, 19107

  • AsclepiX Investigative Site

    Reno, Nevada, 89502

  • AsclepiX Investigative Site

    St. Petersburg, Florida, 33711

  • AsclepiX Investigative Site

    The Woodlands, Texas, 77384

Other trials in United States

About this study

Official title: Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)

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).

Read the detailed description

Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.

Being tested
AXT107 0.1 mg, AXT107 0.25 mg, AXT107 0.5 mg
Keywords
AsclepiX, macular edema, DME, eye diseases, retinal diseases, AXT107, diabetes, duration of action, dose escalation, diabetic retinopathy, retinal degeneration
Medical subject headings
Macular Edema, Eye Diseases, Retinal Diseases, Diabetes Mellitus, Diabetic Retinopathy, Retinal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AXT107 0.1 mgDrug

    Also called Gersizangatide

    Single intravitreal injection of AXT107 0.1 mg/eye

  • AXT107 0.25 mgDrug

    Also called Gersizangatide

    Single intravitreal injection of AXT107 0.25 mg/eye

  • AXT107 0.5 mgDrug

    Also called Gersizangatide

    Single intravitreal injection of AXT107 0.5 mg/eye

Study groups in NCT04697758
Study groupRoleWhat they receive
Low DoseExperimentalAXT107 0.1 mg/eye
Receives: Drug: AXT107 0.1 mg
Mid DoseExperimentalAXT107 0.25 mg/eye
Receives: Drug: AXT107 0.25 mg
High DoseExperimentalAXT107 0.5 mg/eye
Receives: Drug: AXT107 0.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as Assessed by Incidence of Adverse Events (AEs)

    Incidence of ocular (study eye) and systemic AEs

    Measured: Screening to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start10 Dec 2020
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Why it stopped: Adverse Events

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04697758
Sponsor's protocol ID
AXT107-CS101
Acronym
CONGO
Status last verified
Mar 2024
First submitted
17 Dec 2020
Last updated
22 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg in people with Diabetic Macular Edema (DME), run by AsclepiX Therapeutics, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as Assessed by Incidence of Adverse Events (AEs) (time frame: Screening to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04697758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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