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Monoclonal Antibodies

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

Phase 1 & 2
Waitlist Available
Research Sponsored by AsclepiX Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to week 48
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new eye injection called AXT107 in patients with a severe eye condition called nAMD. The goal is to see if it can help reduce the damage caused by the disease. AXT107 has shown promise in reducing damage and improving eye health in early studies.

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Assessed by Incidence of Adverse Events (AEs)
Secondary study objectives
Efficacy as Assessed by Central Retinal Thickness (CST)
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mid DoseExperimental Treatment1 Intervention
AXT107 0.25 mg/eye
Group II: Low DoseExperimental Treatment1 Intervention
AXT107 0.1 mg/eye
Group III: High DoseExperimental Treatment1 Intervention
AXT107 0.5 mg/eye

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Who is running the clinical trial?

AsclepiX Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
21 Total Patients Enrolled
Amir Shojaei, PhDStudy DirectorAsclepix Therapeutics
1 Previous Clinical Trials
6 Total Patients Enrolled
~1 spots leftby Dec 2025
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