ADVM-022 Intravitreal Gene Therapy for Wet AMD

Completed · Phase 1

Conditions studied: Wet Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration

In brief

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.

Key facts

Study ID

NCT03748784

Run by

Adverum Biotechnologies, Inc.

People needed

30

Starts

2018-11-14

Expected to finish

2022-06-22

Last updated by the study team

2023-08-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 50
• Diagnosis of neovascular (wet) AMD
• BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
• Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
• Demonstrated a meaningful response to anti-VEGF therapy
• Willing and able to provide consent

You may not qualify if…

• History of retinal disease in the study eye other than wet AMD
• Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
• History of retinal detachment (with or without repair) in the study eye
• History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
• Uncontrolled glaucoma in the study eye
• Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
• Any previous intraocular or periocular surgery on the study eye within 6 months
• Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
• Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg

Where it is running

• Adverum Clinical Site — Bakersfield, California, United States
• Adverum Clinical Site — Beverly Hills, California, United States
• Adverum Clinical Site — Golden, Colorado, United States
• Adverum Clinical Site — Deerfield Beach, Florida, United States
• Adverum Clinical Site — Reno, Nevada, United States
• Adverum Clinical Site — Philadelphia, Pennsylvania, United States
• Adverum Clinical Site — West Columbia, South Carolina, United States
• Adverum Clinical Site — Nashville, Tennessee, United States
• Adverum Clinical Site — Abilene, Texas, United States
• Adverum Clinical Site — Houston, Texas, United States
• Adverum Clinical Site — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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