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ACTIVE NOT RECRUITING
NCT05536973
PHASE2

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]

Sponsor: Adverum Biotechnologies, Inc.

View on ClinicalTrials.gov

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 4-16 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.

Official title: A Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment-Experienced Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD) [LUNA]

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2022-08-23

Completion Date

2028-08

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

GENETIC

ADVM-022

A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens

GENETIC

ADVM-022

A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens

Locations (39)

Adverum Clinical Site 178

Phoenix, Arizona, United States

Adverum Clinical Site 126

Phoenix, Arizona, United States

Adverum Clinical Site 159

Tucson, Arizona, United States

Adverum Clinical Site 100

Beverly Hills, California, United States

Adverum Clinical Site 172

Encino, California, United States

Adverum Clinical Site 169

Fullerton, California, United States

Adverum Clinical Site 170

Pasadena, California, United States

Adverum Clinical Site 174

Poway, California, United States

Adverum Clinical Site 164

Riverside, California, United States

Adverum Clinical Site 166

Sacramento, California, United States

Adverum Clinical Site 175

Santa Barbara, California, United States

Adverum Clinical Site 116

Lakewood, Colorado, United States

Adverum Clinical Site 165

Waterford, Connecticut, United States

Adverum Clinical Site 124

Deerfield Beach, Florida, United States

Adverum Clinical Site 176

Fort Lauderdale, Florida, United States

Adverum Clinical Site 168

Jacksonville, Florida, United States

Adverum Clinical Site 149

‘Aiea, Hawaii, United States

Adverum Clinical Site 167

Detroit, Michigan, United States

Adverum Clinical Site 161

Royal Oak, Michigan, United States

Adverum Clinical Site 163

Southaven, Mississippi, United States

Adverum Clinical Site 177

Omaha, Nebraska, United States

Adverum Clinical Site 119

Reno, Nevada, United States

Adverum Clinical Site 146

Cherry Hill, New Jersey, United States

Adverum Clinical Site 171

Teaneck, New Jersey, United States

Adverum Clinical Site 122

West Columbia, South Carolina, United States

Adverum Clinical Site 144

Rapid City, South Dakota, United States

Adverum Clinical Site 101

Nashville, Tennessee, United States

Adverum Clinical Site 123

Abilene, Texas, United States

Adverum Clinical Site 154

Austin, Texas, United States

Adverum Clinical Site 108

Bellaire, Texas, United States

Adverum Clinical Site 162

McAllen, Texas, United States

Adverum Clinical Site 151

San Antonio, Texas, United States

Adverum Clinical Site 107

The Woodlands, Texas, United States

Adverum Clinical Site 152

Morgantown, West Virginia, United States

Adverum Clinical Site 502

Nantes, Loire-Atlantique, France

Adverum Clinical Site 501

Lyon, Rhône, France

Adverum Clinical Site 500

Créteil, Val-de-Marne, France

Adverum Clinical Site 600

London, United Kingdom

Adverum Clinical Site 601

Oxford, United Kingdom