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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in best corrected visual acuity (BCVA) from Baseline
Secondary outcome measures
Eye
Mean change in BCVA from Baseline
Mean change in Central Subfield Thickness (CST) from Baseline
+7 more

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
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,757 Total Patients Enrolled
Kalliopi Stasi, MD, PhDStudy DirectorAdverum Biotechnologies, Inc.

Media Library

ADVM-022 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05536973 — Phase 2
Age-Related Macular Degeneration Research Study Groups: Dose 1, Dose 2
Age-Related Macular Degeneration Clinical Trial 2023: ADVM-022 Highlights & Side Effects. Trial Name: NCT05536973 — Phase 2
ADVM-022 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536973 — Phase 2
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05536973 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals that researchers are hoping to achieve with this clinical trial?

"The primary objective of this study, as measured over a 50-week period, is to evaluate the mean change in best corrected visual acuity (BCVA) from baseline. In addition to the primary outcome, this trial will also be assessing secondary outcomes including mean change in BCVA from baseline (as measured by ETDRS), percentage of participants who are supplemental aflibercept injection-free (defined as no supplemental anti-VEGF treatments required post therapy), and percentage of participants without CST fluctuations > 50 μm (defined as no significant changes in central subfield thickness)."

Answered by AI

Can new volunteers still sign up for this experiment?

"Yes, according to the clinicaltrials.gov website, this study is looking for patients right now. The listing says that the trial was first posted on 8/23/2022 and edited on 9/8/2022. They are recruiting for 72 participants from 5 different locations."

Answered by AI

When might we see ADVM-022 on the market?

"ADVM-022 falls into the Phase 2 category, which means that while there is evidence of safety, none exists yet for efficacy. Consequently, we have given it a score of 2."

Answered by AI

What is the total sample size for this research project?

"That is correct, the information available on clinicaltrials.gov seems to suggest that this trial is actively looking for patients right now. This particular trial was posted on 8/23/2022 and then edited last on 9/8/2022. They are hoping to enroll 72 patients at 5 different sites."

Answered by AI

How many hospitals are running this trial?

"Right now, this research is ongoing at 5 different sites. They are situated in cities like Phoenix and Fullerton as well as Aiea. If you want to reduce the amount of travelling needed, be sure to select a location near you."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
Other
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Adverum Clinical Site
Adverum Clinical Site 100
Adverum Clinical Site 166
Other

Why did patients apply to this trial?

Trying for better vision in left eye. The injecdtons worked for a few years but now the eye with wet AMD has become dry and I am searching for something to to help.
PatientReceived no prior treatments
I have AMD and want to: 1) keep it from progressing if I can, and 2) help us all to find ways to treat and even lessen the risk of AMD. I am at high risk of going blind from AMD. My mother and all 3 of her sisters had AMD, but my sisters and cousins to not.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
2022. "Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05536973.
All > Age Related Macular Degeneration > Honolulu
~46 spots leftby Aug 2028
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