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Neovascular (Wet) AMDPhase 1/2NCT06550011

Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

A Phase 1/2 study testing ABI-110 Low Dose, ABI-110 Medium Dose and ABI-110 High Dose in people with Neovascular (Wet) AMD, run by Avirmax Biopharma Inc at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Neovascular (Wet) AMD
What is being tested?
ABI-110 Low Dose, ABI-110 Medium Dose and ABI-110 High Dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
7 Aug 2024to 16 Jan 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General:
  • Must be willing and able to provide written, signed informed consent.
  • Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
  • Study eye:
  • Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
  • The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
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  • BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters)
  • History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
  • Response to anti-VEGF at trial entry

Who cannot join

  • Study or Fellow Eye:
  • Prior gene therapy, either eye
  • Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
  • History of retinal disease other than wAMD or PCV, study eye
  • Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
  • History of (or active) retinal detachment, study eye
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  • Uncontrolled glaucoma (defined as IOP > 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
  • History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
  • Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
  • History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78240

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 1/2a, Open-Label, Multiple-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54- VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.

Read the detailed description

This is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of IVT ABI-110 (AAV2.N54-VEGF-Trap) injection in subjects with wAMD), including symptomatic macular PCV.

This trial will include a screening period, confirmation of response to EYLEA (aflibercept), single administration of ABI-110, and follow-up period of 104 weeks after IVT ABI-110 injection.

Being tested
ABI-110 Low Dose, ABI-110 Medium Dose, ABI-110 High Dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-110 Low DoseDrug

    Low dose. lower than the safety factor of 10 as recommended by the FDA

  • ABI-110 Medium DoseDrug

    Medium dose

  • ABI-110 High DoseDrug

    High Dose

Study groups in NCT06550011
Study groupRoleWhat they receive
Dose level 1ExperimentalLow Dose
Receives: Drug: ABI-110 Low Dose
Dose level 2ExperimentalMedium Dose
Receives: Drug: ABI-110 Medium Dose
Dose level 3ExperimentalHigh Dose
Receives: Drug: ABI-110 High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: 52 weeks

Secondary outcomes (4)

  1. Preliminary Efficacy

    Change from baseline to Week 52 after ABI-110 treatment in BCVA as assessed by ETDRS chart at a starting distance of 4M

    Measured: 52 weeks

  2. Pharmacokinetics and Pharmacodynamics

    Changes in PK and PD by ABI-110 dose level

    Measured: 52 weeks

  3. Immunogenicity

    Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum

    Measured: 52 weeks

  4. Optimal Dose

    To determine the optimal dose of IVT ABI-110 injection for later phases of study

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start7 Aug 2024
  3. Primary completion13 Jan 2027 (estimated)
  4. Study completion16 Jan 2031 (estimated)

Resources

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
Model description
Dose Escalation
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550011
Sponsor's protocol ID
Avirmax ABI-110
Status last verified
Feb 2026
First submitted
25 Jul 2024
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABI-110 Low Dose, ABI-110 Medium Dose and ABI-110 High Dose in people with Neovascular (Wet) AMD, run by Avirmax Biopharma 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Safety and Tolerability (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06550011.

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 12 Feb 2026.

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