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

NCT05536973 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ADVM-022-11
• Study Type: interventional
• Target: 69
• Locations: 3 countries
• Sites: 39

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Aflibercept; Best Corrected Visual Acuity; Adverum; ADVM; ADVM-022; ADVM-022-11; Age-related macular degeneration; Wet macular degeneration; Wet AMD; Choroidal neovascularization; CNV; AAV.7m8; Anti-VEGF therapy; Gene therapy; Blindness; AAV; AAV vector; nAMD; wAMD; Eye disease; Eye diseases

Outcome Measures

Primary Outcomes (3)

• Incidence of ocular and non-ocular adverse events

  Incidence of ocular and non-ocular adverse events

  Up to Week 52

• Severity of ocular and non-ocular adverse events

  Severity of ocular and non-ocular adverse events

  Up to Week 52

• Mean change in best corrected visual acuity (BCVA) from Baseline

  BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

  Baseline up to Week 52

Secondary Outcomes (10)

• Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA

  Baseline up to 5 years

• Mean change in BCVA from Baseline

  Baseline up to 5 years

• Percentage of participants who are supplemental aflibercept injection-free

  Baseline up to 5 years

• Percent reduction in annualized anti-VEGF injections

  Baseline up to 5 years

• Mean change in Central Subfield Thickness (CST) from Baseline

  Baseline up to 5 years

Study Arms (2)

Dose 1

EXPERIMENTAL

A single intravitreal injection of ADVM-022 2E11 vg/eye

Genetic: ADVM-022

Dose 2

EXPERIMENTAL

A single intravitreal injection of ADVM-022 6E10 vg/eye

Genetic: ADVM-022

Interventions

ADVM-022 GENETIC

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

Dose 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants, ≥ 50 years of age
• Willing and able to provide written, signed informed consent for this study
• Demonstrated a meaningful response to anti-VEGF therapy
• Participants must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening for the treatment of choroidal neovascularization secondary to nAMD in the study eye
• Vision of the study eye at Baseline: BCVA in the range of 25 - 83 ETDRS letters, inclusive (approximate Snellen equivalent visual acuity range of 20/25 - 20/320)
• Vision of the non-study eye at Baseline: BCVA ≥ 35 ETDRS letters (approximate Snellen equivalent of 20/200 or better)

You may not qualify if:

• Any condition that could affect the interpretation of results or render the participant at high risk of treatment complications in the opinion of the Investigator
• Ocular or periocular infection or intraocular inflammation in either eye within 1 month prior to or at the Randomization Visit (Day -7)
• Uncontrolled diabetes or HbA1c ≥ 7.0 %
• History or evidence of significant uncontrolled concomitant disease within 6 months of the Screening visit
• Any history of ongoing bleeding disorders or INR \>3.0
• History or evidence of macular or retinal disease other than nAMD
• History or evidence of retinal detachment or retinal pigment epithelium rip/tear
• Uncontrolled ocular hypertension or glaucoma
• Prior treatment with photodynamic therapy or retinal laser for the treatment of nAMD
• Any history of vitrectomy or any other vitreoretinal surgery
• Prior treatment with gene therapy at any time or any non-gene therapy investigational treatment or medical device in the study eye within 3 months of the Screening Visit or 5 half-lives of the investigational medicinal product

Sponsors & Collaborators

• Adverum Biotechnologies, Inc.: lead

Study Sites (39)

Adverum Clinical Site 178

Phoenix, Arizona, 85020, United States

Location

Adverum Clinical Site 126

Phoenix, Arizona, 85053, United States

Location

Adverum Clinical Site 159

Tucson, Arizona, 85704, United States

Location

Adverum Clinical Site 100

Beverly Hills, California, 90211, United States

Location

Adverum Clinical Site 172

Encino, California, 91436, United States

Location

Adverum Clinical Site 169

Fullerton, California, 92835, United States

Location

Adverum Clinical Site 170

Pasadena, California, 91105, United States

Location

Adverum Clinical Site 174

Poway, California, 92064, United States

Location

Adverum Clinical Site 164

Riverside, California, 92505, United States

Location

Adverum Clinical Site 166

Sacramento, California, 95817, United States

Location

Adverum Clinical Site 175

Santa Barbara, California, 93103, United States

Location

Adverum Clinical Site 116

Lakewood, Colorado, 80228, United States

Location

Adverum Clinical Site 165

Waterford, Connecticut, 06385, United States

Location

Adverum Clinical Site 124

Deerfield Beach, Florida, 33064, United States

Location

Adverum Clinical Site 176

Fort Lauderdale, Florida, 33308, United States

Location

Adverum Clinical Site 168

Jacksonville, Florida, 32216, United States

Location

Adverum Clinical Site 149

‘Aiea, Hawaii, 96701, United States

Location

Adverum Clinical Site 167

Detroit, Michigan, 48201, United States

Location

Adverum Clinical Site 161

Royal Oak, Michigan, 48073, United States

Location

Adverum Clinical Site 163

Southaven, Mississippi, 38671, United States

Location

Adverum Clinical Site 177

Omaha, Nebraska, 68105, United States

Location

Adverum Clinical Site 119

Reno, Nevada, 89502, United States

Location

Adverum Clinical Site 146

Cherry Hill, New Jersey, 08034, United States

Location

Adverum Clinical Site 171

Teaneck, New Jersey, 07666, United States

Location

Adverum Clinical Site 122

West Columbia, South Carolina, 29169, United States

Location

Adverum Clinical Site 144

Rapid City, South Dakota, 57701, United States

Location

Adverum Clinical Site 101

Nashville, Tennessee, 37203, United States

Location

Adverum Clinical Site 123

Abilene, Texas, 79606, United States

Location

Adverum Clinical Site 154

Austin, Texas, 78705, United States

Location

Adverum Clinical Site 108

Bellaire, Texas, 77401, United States

Location

Adverum Clinical Site 162

McAllen, Texas, 78503, United States

Location

Adverum Clinical Site 151

San Antonio, Texas, 78240, United States

Location

Adverum Clinical Site 107

The Woodlands, Texas, 77384, United States

Location

Adverum Clinical Site 152

Morgantown, West Virginia, 26506, United States

Location

Adverum Clinical Site 502

Nantes, Loire-Atlantique, 44093, France

Location

Adverum Clinical Site 501

Lyon, Rhône, 69004, France

Location

Adverum Clinical Site 500

Créteil, Val-de-Marne, 94000, France

Location

Adverum Clinical Site 600

London, EC1V 2PD, United Kingdom

Location

Adverum Clinical Site 601

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Blindness; Eye Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Adam Turpcu, PhD

  Adverum Biotechnologies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: August 23, 2022
• Primary Completion: August 26, 2024
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

GB (2); US (34); FR (3)