Dose 1 for Neovascular Age-related Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Adverum Clinical Site, Jacksonville, FL
Neovascular Age-related Macular Degeneration+2 More
ADVM-022 - Genetic
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-12 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product, being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 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.

Eligible Conditions

  • Neovascular Age-related Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neovascular Age-related Macular Degeneration

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Week 26 and Week 50

Week 50
Incidence of ocular and non-ocular adverse events
Severity of ocular and non-ocular adverse events
Week 26
Mean change in BCVA from Baseline
Week 50
Mean change in Central Subfield Thickness (CST) from Baseline
Week 50
Mean change in best corrected visual acuity (BCVA) from Baseline
Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in Best Corrected Visual Acuity (BCVA)
Percentage of participants who are supplemental aflibercept injection-free
Percentage of participants without CST fluctuations > 50 μm
Percentage reduction in anti-VEGF injections

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Neovascular Age-related Macular Degeneration

Trial Design

2 Treatment Groups

Dose 1
1 of 2
Dose 2
1 of 2
Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Dose 1 · No Placebo Group · Phase 2

Dose 1
Genetic
Experimental Group · 1 Intervention: ADVM-022 · Intervention Types: Genetic
Dose 2
Genetic
Experimental Group · 1 Intervention: ADVM-022 · Intervention Types: Genetic

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 26 and week 50
Closest Location: Adverum Clinical Site · Jacksonville, FL
Photo of Jacksonville  1Photo of Jacksonville  2Photo of Jacksonville  3
2022First Recorded Clinical Trial
3 TrialsResearching Neovascular Age-related Macular Degeneration
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to provide written, signed informed consent for this study.
BCVA ≤ 20/32 or ≥ 20/320.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.