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Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

NCT05859776 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question\[s\] it aims to answer are:

* Safety of the maximum tolerable dose of AXT107
* Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring visits through 9 months post single injection.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

AXT107 Low Dose

Single suprachoroidal injection of AXT107 (0.125 mg/eye)

DRUG

AXT107 Mid Dose

Single suprachoroidal injection of AXT107 (0.250 mg/eye)

DRUG

AXT107 High Dose

Single suprachoroidal injection of AXT107 (0.500 mg/eye)

Sponsors & Collaborators

  • AsclepiX Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-03-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859776 on ClinicalTrials.gov