Neovascular Age-Related Macular Degeneration (nAMD)Phase 1/2SHASTANCT04746963
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration
A Phase 1/2 study testing AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg in people with Neovascular Age-Related Macular Degeneration (nAMD), run by AsclepiX Therapeutics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Feb 2021to 1 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
AsclepiX Investigative Site
Abilene, Texas, 79606
AsclepiX Investigative Site
Boston, Massachusetts, 02114
AsclepiX Investigative Site
Eugene, Oregon, 97401
AsclepiX Investigative Site
Gilbert, Arizona, 85053
AsclepiX Investigative Site
Huntingdon Valley, Pennsylvania, 19006
AsclepiX Investigative Site
Los Angeles, California, 90211
AsclepiX Investigative Site
McAllen, Texas, 78503
AsclepiX Investigative Site
Reno, Nevada, 89502
AsclepiX Investigative Site
St. Petersburg, Florida, 33711
AsclepiX Investigative Site
The Woodlands, Texas, 77384
About this study
Official title: Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
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.
Read the detailed 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.
- Being tested
- AXT107 0.1 mg, AXT107 0.25 mg, AXT107 0.5 mg
- Keywords
- AsclepiX, Neovascular Age-Related Macular Degeneration, nAMD, eye diseases, retinal diseases, AXT107, duration of action, dose escalation, macular degeneration
- Medical subject headings
- Eye Diseases, Retinal Diseases, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXT107 0.1 mgDrug
Also called Gersizangatide
Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
AXT107 0.25 mgDrug
Also called Gersizangatide
Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
AXT107 0.5 mgDrug
Also called Gersizangatide
Single intravitreal injection of AXT107 0.5 mg/eye (high dose)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | AXT107 0.1 mg/eye Receives: Drug: AXT107 0.1 mg |
| Mid Dose | Experimental | AXT107 0.25 mg/eye Receives: Drug: AXT107 0.25 mg |
| High Dose | Experimental | AXT107 0.5 mg/eye Receives: Drug: AXT107 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assessed by Incidence of Adverse Events (AEs)
Incidence of ocular (study eye) and systemic adverse events (AEs)
Measured: Screening to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Adverse Events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AsclepiX Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Shojaei, PhD, Study director, Asclepix Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746963
- Sponsor's protocol ID
- AXT107-CS102
- Acronym
- SHASTA
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2021
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT04746963
- Acronym / sponsor ID
- SHASTA / AXT107-CS102
- Keywords
- AsclepiX, Neovascular Age-Related Macular Degeneration, nAMD, eye diseases, retinal diseases, AXT107, duration of action, dose escalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse Events
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AsclepiX Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: AXT107 0.1 mgAXT107 0.1 mg/eye |
| Mid Dose | Experimental | Drug: AXT107 0.25 mgAXT107 0.25 mg/eye |
| High Dose | Experimental | Drug: AXT107 0.5 mgAXT107 0.5 mg/eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXT107 0.1 mgAlso: GersizangatideSingle intravitreal injection of AXT107 0.1 mg/eye (low dose) | Drug | Low Dose |
| AXT107 0.25 mgAlso: GersizangatideSingle intravitreal injection of AXT107 0.25 mg/eye (mid dose) | Drug | Mid Dose |
| AXT107 0.5 mgAlso: GersizangatideSingle intravitreal injection of AXT107 0.5 mg/eye (high dose) | Drug | High Dose |
Primary outcome
Number of Participants Assessed by Incidence of Adverse Events (AEs)
Time frame: Screening to Week 48
Incidence of ocular (study eye) and systemic adverse events (AEs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Shojaei, PhD study director
Asclepix Therapeutics
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AXT107 0.1 mg, AXT107 0.25 mg and AXT107 0.5 mg in people with Neovascular Age-Related Macular Degeneration (nAMD), run by AsclepiX Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Assessed by Incidence of Adverse Events (AEs) (time frame: Screening to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.