NCT04697758

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

December 17, 2020

Results QC Date

January 29, 2024

Last Update Submit

March 20, 2024

Conditions

Diabetic Macular Edema (DME)

Keywords

AsclepiXmacular edemaDMEeye diseasesretinal diseasesAXT107diabetesduration of actiondose escalationdiabetic retinopathyretinal degeneration

Outcome Measures

Primary Outcomes (1)

  • Safety as Assessed by Incidence of Adverse Events (AEs)

    Incidence of ocular (study eye) and systemic AEs

    Screening to Week 48

Study Arms (3)

Low Dose

EXPERIMENTAL

AXT107 0.1 mg/eye

Drug: AXT107 0.1 mg

Mid Dose

EXPERIMENTAL

AXT107 0.25 mg/eye

Drug: AXT107 0.25 mg

High Dose

EXPERIMENTAL

AXT107 0.5 mg/eye

Drug: AXT107 0.5 mg

Interventions

AXT107 0.1 mgDRUG

Single intravitreal injection of AXT107 0.1 mg/eye

Also known as: Gersizangatide
Low Dose
AXT107 0.25 mgDRUG

Single intravitreal injection of AXT107 0.25 mg/eye

Also known as: Gersizangatide
Mid Dose
AXT107 0.5 mgDRUG

Single intravitreal injection of AXT107 0.5 mg/eye

Also known as: Gersizangatide
High Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

AsclepiX Investigative Site

Gilbert, Arizona, 85053, United States

Location

AsclepiX Investigative Site

Los Angeles, California, 90211, United States

Location

AsclepiX Investigative Site

St. Petersburg, Florida, 33711, United States

Location

AsclepiX Investigative Site

Boston, Massachusetts, 02114, United States

Location

AsclepiX Investigative Site

Reno, Nevada, 89502, United States

Location

AsclepiX Investigative Site

Eugene, Oregon, 97401, United States

Location

AsclepiX Investigative Site

Philadelphia, Pennsylvania, 19107, United States

Location

AsclepiX Investigative Site

Abilene, Texas, 79606, United States

Location

AsclepiX Investigative Site

McAllen, Texas, 78550, United States

Location

AsclepiX Investigative Site

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Macular EdemaEye DiseasesRetinal DiseasesDiabetes MellitusDiabetic RetinopathyRetinal Degeneration

Interventions

AXT107

Condition Hierarchy (Ancestors)

Macular DegenerationGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEye Diseases, Hereditary

Results Point of Contact

Title
Dr A Shojaei
Organization
AsclepiX Therapeutics
ashojaei@asclepix.com
8005723545

Study Officials

  • Amir Shojaei, PhD

    Asclepix Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

January 6, 2021

Study Start

December 10, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

March 22, 2024

Results First Posted

March 22, 2024

Record last verified: 2024-03

Locations

US(10)