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Gene Therapy
Gene Therapy (ADVM-022) for Age-Related Macular Degeneration
Phase 2
Waitlist Available
Research Sponsored by Adverum Biotechnologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a gene therapy product, ADVM-022, for the treatment of neovascular or wet age-related macular degeneration (nAMD). The product is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
Who is the study for?
This trial is for people over 50 with wet age-related macular degeneration (nAMD) who've had at least 2-3 anti-VEGF injections in the past 4-6 months. They must have shown improvement from these treatments and have a certain level of vision acuity. Those with uncontrolled diseases, recent eye infections or surgeries, or other retinal issues can't participate.
What is being tested?
ADVM-022, a gene therapy product designed to reduce treatment frequency for nAMD by providing sustained release of aflibercept after one injection. The study aims to see if this single treatment can maintain or improve patients' vision compared to regular anti-VEGF injections.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with intravitreal injections such as eye inflammation, infection risk increase, bleeding complications, and possibly immune reactions due to the gene therapy aspect.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in best corrected visual acuity (BCVA) from Baseline
Secondary study objectives
Eye
Mean change in BCVA from Baseline
Mean change in Central Subfield Thickness (CST) from Baseline
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose 2Experimental Treatment1 Intervention
A single intravitreal injection of ADVM-022 6E10 vg/eye
Group II: Dose 1Experimental Treatment1 Intervention
A single intravitreal injection of ADVM-022 2E11 vg/eye
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADVM-022
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Adverum Biotechnologies, Inc.Lead Sponsor
8 Previous Clinical Trials
203 Total Patients Enrolled
3 Trials studying Macular Degeneration
93 Patients Enrolled for Macular Degeneration
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,482 Total Patients Enrolled
1 Trials studying Macular Degeneration
576 Patients Enrolled for Macular Degeneration
Adam Turpcu, PhDStudy DirectorAdverum Biotechnologies, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a retinal detachment or tear in the past.I haven't had gene therapy or been part of eye studies recently.I am 50 years old or older.I am currently receiving anti-VEGF injections for wet AMD and have had at least 2 injections in the last 4 months.I have had surgery on the back part of my eye.My diabetes is not under control or my HbA1c is 7.0% or higher.I have had photodynamic therapy or retinal laser for wet AMD.I have uncontrolled high eye pressure or glaucoma.I have a history of eye diseases other than wet AMD.I haven't had eye infections or inflammation in the last month.I have a bleeding disorder or my blood doesn't clot normally.I haven't had a serious uncontrolled illness in the last 6 months.My condition improved with anti-VEGF treatment.I am currently being treated for wet AMD with at least 2 injections in the last 4 months.Your visual acuity is between 20/32 and 20/320 according to the Early Treatment Diabetic Retinopathy Study (ETDRS) Snellen scale.My condition improved with anti-VEGF treatment.I have active eye disease involving the center of my vision confirmed by a specific eye scan.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 1
- Group 2: Dose 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Macular Degeneration Patient Testimony for trial: Trial Name: NCT05536973 — Phase 2
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