ABI-110 for Wet Age-Related Macular Degeneration
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Avirmax Biopharma Inc
Must be taking: Anti-VEGF
Must not be taking: Intravitreal steroids
Disqualifiers: Retinal detachment, Uncontrolled glaucoma, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345What 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.
16789How 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.
110111213Eligibility 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.
+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.
+6 more
Trial 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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
California Retina ConsultantsBakersfield, CA
Retina Consultants of TexasThe Woodlands, TX
Retina Research Institute of TexasAbilene, TX
Bay Area Retina AssociatesWalnut Creek, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Avirmax Biopharma IncLead Sponsor
References
Intravitreous injection of AAV2-sFLT01 in patients with advanced neovascular age-related macular degeneration: a phase 1, open-label trial. [2022]Long-term intraocular injections of vascular endothelial growth factor (VEGF)-neutralising proteins can preserve central vision in many patients with neovascular age-related macular degeneration. We tested the safety and tolerability of a single intravitreous injection of an AAV2 vector expressing the VEGF-neutralising protein sFLT01 in patients with advanced neovascular age-related macular degeneration.
A phase I study of intravitreal vascular endothelial growth factor trap-eye in patients with neovascular age-related macular degeneration. [2021]To determine the safety, tolerability, maximum tolerated dose, and bioactivity of an intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye, a fusion protein of binding domains from human VEGF receptors 1 and 2 with human immunoglobulin-G Fc that binds VEGF family members, in patients with neovascular age-related macular degeneration (AMD).
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]To assess the safety, pharmacokinetics, and biological activity of IV administration of vascular endothelial growth factor trap (VEGF Trap), a recombinant protein containing the binding domains of VEGF receptors 1 and 2, in patients with neovascular age-related macular degeneration (AMD).
Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. [2012]To determine bioactivity and duration of effect of intravitreal aflibercept injection (also known as vascular endothelial growth factor Trap-Eye) for neovascular age-related macular degeneration (AMD).
Anti-VEGF AAV2 injections: The fewer the better. [2019]A single intravitreal injection of AAV2 provides sustained delivery of anti-VEGF protein for the treatment of neovascular AMD.
Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. [2022]Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.
SUSTAINED BIWEEKLY AFLIBERCEPT FOR REFRACTORY NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The Prospective TRISTAR Study. [2023]To assess the safety and efficacy of biweekly (every 2 weeks) intravitreal aflibercept injections (IAI) 2 mg in eyes with refractory neovascular age-related macular degeneration (NVAMD).
Long-term safety and efficacy of ziv-aflibercept in retinal diseases. [2022]To investigate the long-term safety of intravitreal ziv-aflibercept in eyes receiving six or more intravitreal injections of ziv-aflibercept, an off-label substitute to the approved aflibercept.
Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. [2022]To assess the ocular and systemic safety of intravitreal aflibercept injection (IAI) compared with controls in IAI trials in neovascular age-related macular degeneration (nAMD), macular edema following central retinal vein occlusion (MEfCRVO), macular edema following branch retinal vein occlusion (MEfBRVO), and diabetic macular edema (DME).
Gene, Cell and Antibody-Based Therapies for the Treatment of Age-Related Macular Degeneration. [2020]Here we discuss antibody, cell and gene-based therapies that are currently available and under investigation for both wet and dry age-related macular degeneration (AMD). We initially discuss ocular anatomy, AMD modelling as well as the underlying pathophysiology of AMD. The antibody-based trials which have revolutionised the management of wet AMD are reviewed. The latest concepts in antibody therapy for wet AMD such as the port delivery systems, bispecific antibodies, designed ankyrin repeat protein (DARPINs) and brolucizumab are explored. Furthermore, the antibody-based trials targeting the complement pathway to reduce progression of geographic atrophy (GA) in dry AMD are discussed. Stem cell therapy and gene therapy are novel treatment modalities with no established clinical use in wet or dry AMD. Here, we discuss their efficacy so far in clinical trials. Their benefits and risk in the treatment of both wet and dry AMD are evaluated.
Treatment for neovascular age related macular degeneration: The state of the art. [2017]With the introduction in the clinical practice of drugs inhibiting vascular endothelial growth factor (VEGF) the visual outcomes of patients with neovascular age related macular degeneration (AMD) dramatically improved. Since 2006 repeated intravitreal injections of anti-VEGF became the standard of care for the treatment of neovascular AMD. This review provides an overview of available data form clinical trials supporting the use of anti-VEGF molecules for the treatment of this condition. Several questions remain open, in particular the regimen of treatment, the frequency of injection, the safety of the different drugs, and the poor response to the treatment in some cases. Therefore, new agents and alternative delivery are currently under evaluation.
Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. [2023]To evaluate the safety and efficacy of repeat injections of Brimonidine Drug Delivery System (Brimo DDS) Generation 2 (Gen 2) containing 400-μg brimonidine in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Initial utilization of aflibercept in exudative age-related macular degeneration. [2017]Intravitreal aflibercept, a fusion protein with high affinity for vascular endothelial growth factor, offers an alternative treatment for exudative age-related macular degeneration. Preclinical studies and early and late phase clinical trials suggest that aflibercept's high binding affinity may impart greater durability of activity and increased efficacy compared to ranibizumab or bevacizumab.