18 Participants Needed

ABI-110 for Wet Age-Related Macular Degeneration

Recruiting at 4 trial locations
WM
Overseen ByWendy Murahashi
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Avirmax Biopharma Inc
Must be taking: Anti-VEGF
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require a history of anti-VEGF injections, so you may need to continue those treatments.

What data supports the effectiveness of the treatment ABI-110 for Wet Age-Related Macular Degeneration?

Research shows that injections of AAV2 vectors, which are part of ABI-110, can deliver proteins that block VEGF (a protein that causes vision problems) and help preserve vision in patients with age-related macular degeneration.12345

What safety data exists for ABI-110 (AAV2.N54-VEGF Trap) in humans?

The safety of treatments similar to ABI-110, like aflibercept and AAV2-sFLT01, has been studied in people with eye conditions like wet age-related macular degeneration. These studies generally show that such treatments are safe for use in the eye, with some patients experiencing mild side effects like eye discomfort or increased eye pressure.16789

How is the treatment ABI-110 different from other treatments for wet age-related macular degeneration?

ABI-110 is unique because it uses gene therapy to deliver a VEGF-neutralizing protein directly into the eye, potentially reducing the need for frequent injections that are common with other treatments.110111213

Eligibility Criteria

This trial is for patients with wet age-related macular degeneration (wAMD), including those with symptomatic macular polypoidal choroidal vasculopathy (PCV). Specific eligibility criteria are not provided, but typically include a confirmed diagnosis and no contraindications for treatment.

Inclusion Criteria

Must be willing and able to provide written, signed informed consent
I am between 50 and 89 years old.
My wet AMD diagnosis, including PCV, is confirmed by a specialized center.
See 5 more

Exclusion Criteria

I haven't had any eye injections except for anti-VEGF in the last 6 months.
I have had gene therapy on my eye.
I have had photodynamic therapy or laser treatment on my eye.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Confirmation of Response

Confirmation of response to EYLEA (aflibercept) before administration of ABI-110

2-4 weeks

Treatment

Single administration of ABI-110 (AAV2.N54-VEGF-Trap) injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and preliminary efficacy after treatment

104 weeks
Regular visits over 104 weeks

Treatment Details

Interventions

  • ABI-110
Trial OverviewThe study tests three different doses of ABI-110, an experimental drug delivered through an eye injection, to evaluate its safety and early effectiveness in treating wAMD and PCV.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Dose level 3Experimental Treatment1 Intervention
High Dose
Group II: Dose level 2Experimental Treatment1 Intervention
Medium Dose
Group III: Dose level 1Experimental Treatment1 Intervention
Low Dose

ABI-110 is already approved in United States for the following indications:

🇺🇸
Approved in United States as ABI-110 for:
  • Wet Age-related Macular Degeneration (AMD)
  • Polypoidal Choroidal Vasculopathy (PCV)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Avirmax Biopharma Inc

Lead Sponsor

Trials
1
Recruited
20+

Findings from Research

The study demonstrated that a single intravitreous injection of AAV2-sFLT01 is safe and well tolerated in patients with advanced neovascular age-related macular degeneration, with only a few mild adverse events reported.
Among the patients treated, some showed significant improvements in vision and reduction of fluid in the eye, indicating potential efficacy, although further research is needed to understand variability in treatment response.
Intravitreous injection of AAV2-sFLT01 in patients with advanced neovascular age-related macular degeneration: a phase 1, open-label trial.Heier, JS., Kherani, S., Desai, S., et al.[2022]
The study involved 21 patients with neovascular age-related macular degeneration (AMD) and found that intravitreal injections of VEGF Trap-Eye were well tolerated, with no serious adverse events or intraocular inflammation reported.
Patients receiving the highest doses (2 mg and 4 mg) showed significant improvements in visual acuity, with an average increase of 13.5 letters, and reductions in foveal thickness, indicating the bioactivity of the treatment.
A phase I study of intravitreal vascular endothelial growth factor trap-eye in patients with neovascular age-related macular degeneration.Nguyen, QD., Shah, SM., Browning, DJ., et al.[2021]
In a clinical trial involving 25 patients with neovascular age-related macular degeneration, the maximum tolerated dose of intravenous VEGF Trap was determined to be 1.0 mg/kg, which effectively reduced excess retinal thickness by about 60%.
While most adverse events were mild to moderate, two patients at the highest dose experienced serious side effects, leading to their withdrawal from the study, highlighting the need for careful dose management.
A phase I trial of an IV-administered vascular endothelial growth factor trap for treatment in patients with choroidal neovascularization due to age-related macular degeneration.Nguyen, QD., Shah, SM., Hafiz, G., et al.[2009]

References

Intravitreous injection of AAV2-sFLT01 in patients with advanced neovascular age-related macular degeneration: a phase 1, open-label trial. [2022]
A phase I study of intravitreal vascular endothelial growth factor trap-eye in patients with neovascular age-related macular degeneration. [2021]
A phase I trial of an IV-administered vascular endothelial growth factor trap for treatment in patients with choroidal neovascularization due to age-related macular degeneration. [2009]
Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. [2012]
Anti-VEGF AAV2 injections: The fewer the better. [2019]
Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. [2022]
SUSTAINED BIWEEKLY AFLIBERCEPT FOR REFRACTORY NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The Prospective TRISTAR Study. [2023]
Long-term safety and efficacy of ziv-aflibercept in retinal diseases. [2022]
Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. [2022]
Gene, Cell and Antibody-Based Therapies for the Treatment of Age-Related Macular Degeneration. [2020]
Treatment for neovascular age related macular degeneration: The state of the art. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Initial utilization of aflibercept in exudative age-related macular degeneration. [2017]