Clinical trial NCT04697758: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
Official title: Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema (DME)
Keywords: AsclepiX
macular edema
DME
eye diseases
retinal diseases
AXT107
diabetes
duration of action
dose escalation
diabetic retinopathy
retinal degeneration
Lead sponsor: AsclepiX Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Safety as Assessed by Incidence of Adverse Events (AEs)
timeFrame: Screening to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: AsclepiX Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: AsclepiX Investigative Site
state: California
city: Saint Petersburg
country: United States
facility: AsclepiX Investigative Site
state: Florida
city: Boston
country: United States
facility: AsclepiX Investigative Site
state: Massachusetts
city: Reno
country: United States
facility: AsclepiX Investigative Site
state: Nevada
city: Eugene
country: United States
facility: AsclepiX Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: AsclepiX Investigative Site
state: Pennsylvania
city: Abilene
country: United States
facility: AsclepiX Investigative Site
state: Texas
city: McAllen
country: United States
facility: AsclepiX Investigative Site
state: Texas
city: The Woodlands
country: United States
facility: AsclepiX Investigative Site
state: Texas
Study officials:
affiliation: Asclepix Therapeutics
name: Amir Shojaei, PhD
role: STUDY_DIRECTOR
References: