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ADVM-022 Intravitreal Gene Therapy for Wet AMD

Phase 1
Completed
Conditions
Wet Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Interventions
Biological: ADVM-022
Registration Number
NCT03748784
Lead Sponsor
Adverum Biotechnologies, Inc.
Brief Summary

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.

Detailed Description

This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Dose 1ADVM-0226E11 vg of ADVM-022
Dose 2ADVM-0222E11 vg of ADVM-022
Primary Outcome Measures
NameTimeMethod
Type, severity, and incidence of ocular and systemic adverse events (AEs)104 weeks

Type, severity, and incidence of ocular and systemic adverse events (AEs)

Secondary Outcome Measures
NameTimeMethod
Change in central subfield thickness (CST) and macular volume measured by SD-OCT104 weeks

Change in central subfield thickness (CST) and macular volume measured by SD-OCT

Percentage of subjects without intraretinal fluid over time104 weeks

Percentage of subjects without intraretinal fluid over time

Change in best corrected visual acuity (BCVA)104 weeks

Change in best corrected visual acuity (BCVA)

Mean number of anti-VEGF injections over time104 weeks

Mean number of anti-VEGF injections over time

Percentage of subjects requiring anti-VEGF injections over time104 weeks

Percentage of subjects requiring anti-VEGF injections over time

Percentage of subjects without subretinal fluid over time104 weeks

Percentage of subjects without subretinal fluid over time

Trial Locations

Locations (1)

Adverum Clinical Site

🇺🇸

The Woodlands, Texas, United States

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