ADVM-022 Intravitreal Gene Therapy for Wet AMD

Neovascular Age-related Macular Degeneration Clinical Trial

— OPTIC  

Official title:

An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748784
• Other study ID #: ADVM-022-01
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2018
• Est. completion date: June 22, 2022

Study information

• Verified date: August 2023
• Source: Adverum Biotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Biological:
• ADVM-022
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Adverum Biotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, severity, and incidence of ocular and systemic adverse events (AEs)	Type, severity, and incidence of ocular and systemic adverse events (AEs)	104 weeks
Secondary	Change in best corrected visual acuity (BCVA)	Change in best corrected visual acuity (BCVA)	104 weeks
Secondary	Change in central subfield thickness (CST) and macular volume measured by SD-OCT	Change in central subfield thickness (CST) and macular volume measured by SD-OCT	104 weeks
Secondary	Percentage of subjects requiring anti-VEGF injections over time	Percentage of subjects requiring anti-VEGF injections over time	104 weeks
Secondary	Mean number of anti-VEGF injections over time	Mean number of anti-VEGF injections over time	104 weeks
Secondary	Percentage of subjects without intraretinal fluid over time	Percentage of subjects without intraretinal fluid over time	104 weeks
Secondary	Percentage of subjects without subretinal fluid over time	Percentage of subjects without subretinal fluid over time	104 weeks