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Virus Therapy
ABI-110 for Wet Age-Related Macular Degeneration
Phase 1 & 2
Recruiting
Research Sponsored by Avirmax Biopharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
Must not have
Prior gene therapy, either eye
Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test the safety and tolerability of IVT ABI-110 in patients with wet macular degeneration, including symptomatic macular PCV."
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, intravitreal injections like ABI-110 may cause eye irritation or discomfort, increased intraocular pressure, bleeding inside the eye, or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 89 years old.
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My wet AMD diagnosis, including PCV, is confirmed by a specialized center.
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I have responded to anti-VEGF treatment before joining the trial.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had gene therapy on my eye.
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I have had photodynamic therapy or laser treatment on my eye.
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I have had eye surgery that could affect medication absorption.
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I do not have any current eye infections or a history of certain eye inflammations.
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I have a history of eye diseases other than wet AMD or PCV in my study eye.
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I have a condition in my eye that stops my vision from getting better.
Select...
I have had, or currently have, a detached retina in the eye being studied.
Select...
I have glaucoma with an eye pressure over 25 mmHg that isn't controlled by treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability
Secondary study objectives
Immunogenicity
Optimal Dose
Pharmacokinetics and Pharmacodynamics
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Find a Location
Who is running the clinical trial?
Avirmax Biopharma IncLead Sponsor