Neovascular Age-related Macular DegenerationPhase 1/2DISCOVERNCT05859776
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
A Phase 1/2 study testing AXT107 Low Dose, AXT107 Mid Dose and AXT107 High Dose in people with Neovascular Age-related Macular Degeneration, run by AsclepiX Therapeutics, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- AXT107 Low Dose, AXT107 Mid Dose and AXT107 High Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Dec 2023to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator
- Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator
- BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)
- BCVA of 34 ETDRS letters or better (20/200 or better Snellen equivalent) in the non-study eye at Baseline (Day 0)
- Able and willing to give signed informed consent and follow study instructions
- Has been/is a prior partial responder to an anti-VEGF agent
Who cannot join
- Previously treated patients who are non-responders to anti-VEGF as determined by the Investigator
- Any prior use of Brolucizumab; use of Aflibercept within 8 weeks or use of Ranibizumab or Bevacizumab within 6 weeks from Baseline (Day 0) in the study eye
- Any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract)
- Any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of AMD (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy)
- Other causes of CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the Investigator
- Chronic uveitis or ongoing clinically significant infection or inflammation (e.g., keratitis, scleritis) in either eye
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Asheville Eye Associates
Asheville, North Carolina, 28803
Erie Retina Research
Erie, Pennsylvania, 16507
New England Retina Consultants
Springfield, Massachusetts, 01107
The Retina Institue
St Louis, Missouri, 63128
About this study
Official title: Phase 1/2a Study of the Safety and Bioactivity of AXT107 Injected Suprachoroidally in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
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.
- Being tested
- AXT107 Low Dose, AXT107 Mid Dose, AXT107 High Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXT107 Low DoseDrug
Also called Gersizangatide
Single suprachoroidal injection of AXT107 (0.125 mg/eye)
AXT107 Mid DoseDrug
Also called Gersizangatide
Single suprachoroidal injection of AXT107 (0.250 mg/eye)
AXT107 High DoseDrug
Also called Gersizangatide
Single suprachoroidal injection of AXT107 (0.500 mg/eye)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | AXT107 0.125 mg/eye Receives: Drug: AXT107 Low Dose |
| Mid Dose | Experimental | AXT107 0.250 mg/eye Receives: Drug: AXT107 Mid Dose |
| High Dose | Experimental | AXT107 0.500 mg/eye Receives: Drug: AXT107 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Primary Outcome Measure:
1.Safety as Assessed by change from baseline in Incidence of Adverse Events (AEs) Incidence of ocular (study eye) and systemic AEs
[Time Frame: Screening to Week 40]
Measured: 40 Weeks
Secondary outcomes (3)
Mean Change in Central Subfield Thickness (CST)
Secondary Outcome Measures:
Efficacy as Assessed by Central Subfield Thickness (CST, measured in µm) Mean change in CST assessed by spectral domain optical coherence tomography
[Time Frame: Day 0 to Week 40]
Measured: 40 Weeks
Mean Change in Visual Function
Secondary Outcome Measures:
Visual Function as Assessed by Mean change in Best Corrected Visual Acuity (BCVA) (number of letters in Early Treatment Diabetic Retinopathy Study (EDTRS) chart)
Measured: Day 0 to Week 40
Visual Function Subgroup Analysis
Secondary Outcome Measures:
Visual Function as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart Percentage of subjects improving ≥5, ≥10, and ≥15 letters in Best Corrected Visual Acuity (BCVA)
Measured: Day 0 to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start19 Dec 2023
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AsclepiX Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859776
- Sponsor's protocol ID
- AXT107-CS104
- Acronym
- DISCOVER
- Status last verified
- May 2024
- First submitted
- 24 Mar 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 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 Injected Suprachoroidally in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT05859776
- Acronym / sponsor ID
- DISCOVER / AXT107-CS104
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AsclepiX Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Low DoseAXT107 0.125 mg/eye |
| Mid Dose | Experimental | Drug: AXT107 Mid DoseAXT107 0.250 mg/eye |
| High Dose | Experimental | Drug: AXT107 High DoseAXT107 0.500 mg/eye |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 years of age or older
- Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator
- Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator
- BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)
- BCVA of 34 ETDRS letters or better (20/200 or better Snellen equivalent) in the non-study eye at Baseline (Day 0)
Key exclusion criteria (6 listed)
- Previously treated patients who are non-responders to anti-VEGF as determined by the Investigator
- Any prior use of Brolucizumab; use of Aflibercept within 8 weeks or use of Ranibizumab or Bevacizumab within 6 weeks from Baseline (Day 0) in the study eye
- Any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract)
- Any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of AMD (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy)
- Other causes of CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the Investigator
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 Low DoseAlso: GersizangatideSingle suprachoroidal injection of AXT107 (0.125 mg/eye) | Drug | Low Dose |
| AXT107 Mid DoseAlso: GersizangatideSingle suprachoroidal injection of AXT107 (0.250 mg/eye) | Drug | Mid Dose |
| AXT107 High DoseAlso: GersizangatideSingle suprachoroidal injection of AXT107 (0.500 mg/eye) | Drug | High Dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 40 Weeks
Primary Outcome Measure: 1.Safety as Assessed by change from baseline in Incidence of Adverse Events (AEs) Incidence of ocular (study eye) and systemic AEs [Time Frame: Screening to Week 40]
3 secondary outcomes
Mean Change in Central Subfield Thickness (CST)
Time frame: 40 Weeks
Mean Change in Visual Function
Time frame: Day 0 to Week 40
Visual Function Subgroup Analysis
Time frame: Day 0 to Week 40
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Low Dose, AXT107 Mid Dose and AXT107 High Dose in people with Neovascular Age-related Macular Degeneration, run by AsclepiX Therapeutics, Inc. at 4 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 40 Weeks). 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 6 May 2024.