SHASTA: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration

• Sponsor: AsclepiX Therapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04746963
• Collaborator: (none)
• Enrollment: 18
• Locations: 10
• Arms: 3
• Anticipated Duration (Months): 19.9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This 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 nAMD.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-Related Macular Degeneration (nAMD)	Drug: AXT107 0.1 mg; Drug: AXT107 0.25 mg; Drug: AXT107 0.5 mg	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose AXT107 0.1 mg/eye	Drug: AXT107 0.1 mg; Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
Experimental: Mid Dose AXT107 0.25 mg/eye	Drug: AXT107 0.25 mg; Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
Experimental: High Dose AXT107 0.5 mg/eye	Drug: AXT107 0.5 mg; Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

Outcome Measures

Primary Outcome Measures

1. Safety as Assessed by Incidence of Adverse Events (AEs) [Screening to Week 48]

   Incidence of ocular (study eye) and systemic AEs

Secondary Outcome Measures

1. Efficacy as Assessed by Central Retinal Thickness (CST) [Day 0 to Week 48]

   Mean change in CST assessed by spectral domain optical coherence tomography

2. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart [Day 0 to Week 48]

   Mean change in Best Corrected Visual Acuity (BCVA)

3. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart [Day 0 to Week 48]

   Percentage of subjects improving ≥5, ≥10, and ≥15 letters in Best Corrected Visual Acuity (BCVA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• Willing and able to comply with clinic visits and study-related procedures

• Provide signed inform consent

Exclusion Criteria:

• Macular edema or CMV secondary to any causes other than AMD in the study eye

• Previously-treated patients who are not responders to anti-VEGF

• Any condition that may preclude improvement in visual acuity in the study eye

• Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye

Note: Other inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AsclepiX Investigative Site	Gilbert	Arizona	United States	85053
2	AsclepiX Investigative Site	Los Angeles	California	United States	90211
3	AsclepiX Investigative Site	Saint Petersburg	Florida	United States	33711
4	AsclepiX Investigative Site	Boston	Massachusetts	United States	02114
5	AsclepiX Investigative Site	Reno	Nevada	United States	89502
6	AsclepiX Investigative Site	Eugene	Oregon	United States	97401
7	AsclepiX Investigative Site	Huntingdon Valley	Pennsylvania	United States	19006
8	AsclepiX Investigative Site	Abilene	Texas	United States	79606
9	AsclepiX Investigative Site	McAllen	Texas	United States	78503
10	AsclepiX Investigative Site	The Woodlands	Texas	United States	77384

Sponsors and Collaborators

• AsclepiX Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AsclepiX Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04746963
• Other Study ID Numbers: AXT107-CS102
• First Posted: Feb 10, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AsclepiX Therapeutics, Inc.: AsclepiX; Neovascular Age-Related Macular Degeneration; nAMD; eye diseases; retinal diseases; AXT107; duration of action; dose escalation; macular degeneration
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

No Results Posted as of Jul 20, 2022