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

Asclepix Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Diabetic Macular Edema (DME)

Treatments: Drug: AXT107 0.25 mg; Drug: AXT107 0.5 mg; Drug: AXT107 0.1 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04697758

AXT107-CS101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

6 participants in 3 patient groups

Low Dose

Experimental group

Description:

AXT107 0.1 mg/eye

Treatment:

Drug: AXT107 0.1 mg

Mid Dose

Experimental group

Description:

AXT107 0.25 mg/eye

Treatment:

Drug: AXT107 0.25 mg

High Dose

Experimental group

Description:

AXT107 0.5 mg/eye

Treatment:

Drug: AXT107 0.5 mg