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Monoclonal Antibodies
AXT107 0.1 mg for 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
Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to week 48
Awards & highlights
SHASTA Trial Summary
This trial is testing a new drug for nAMD (neovascular age-related macular degeneration). The drug will be injected into the eye and the safety, tolerability, and effectiveness will be monitored for 48 weeks.
Eligible Conditions
- Age-Related Macular Degeneration
SHASTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSHASTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Assessed by Incidence of Adverse Events (AEs)
Secondary outcome measures
Efficacy as Assessed by Central Retinal Thickness (CST)
Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart
SHASTA 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
Frequently Asked Questions
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