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Clinical Trials in France / NCT05536973
Active, not recruiting Phase 2

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

NCT05536973 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2022-08-23
Last updated
2025-08-22

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

ADVM-022ADVM-022

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

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

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Adverum Clinical Site 178 Phoenix Arizona
Adverum Clinical Site 126 Phoenix Arizona
Adverum Clinical Site 159 Tucson Arizona
Adverum Clinical Site 100 Beverly Hills California
Adverum Clinical Site 172 Encino California
Adverum Clinical Site 169 Fullerton California
Adverum Clinical Site 170 Pasadena California
Adverum Clinical Site 174 Poway California
Adverum Clinical Site 164 Riverside California
Adverum Clinical Site 166 Sacramento California
Adverum Clinical Site 175 Santa Barbara California
Adverum Clinical Site 116 Lakewood Colorado
Adverum Clinical Site 165 Waterford Connecticut
Adverum Clinical Site 124 Deerfield Beach Florida
Adverum Clinical Site 176 Fort Lauderdale Florida
Adverum Clinical Site 168 Jacksonville Florida
Adverum Clinical Site 149 ‘Aiea Hawaii
Adverum Clinical Site 167 Detroit Michigan
Adverum Clinical Site 161 Royal Oak Michigan
Adverum Clinical Site 163 Southaven Mississippi
Adverum Clinical Site 177 Omaha Nebraska
Adverum Clinical Site 119 Reno Nevada
Adverum Clinical Site 146 Cherry Hill New Jersey
Adverum Clinical Site 171 Teaneck New Jersey
Adverum Clinical Site 122 West Columbia South Carolina
Adverum Clinical Site 144 Rapid City South Dakota
Adverum Clinical Site 101 Nashville Tennessee
Adverum Clinical Site 123 Abilene Texas
Adverum Clinical Site 154 Austin Texas
Adverum Clinical Site 108 Bellaire Texas
Adverum Clinical Site 162 McAllen Texas
Adverum Clinical Site 151 San Antonio Texas
Adverum Clinical Site 107 The Woodlands Texas
Adverum Clinical Site 152 Morgantown West Virginia
Adverum Clinical Site 502 Nantes Loire-Atlantique
Adverum Clinical Site 501 Lyon Rhône
Adverum Clinical Site 500 Créteil Val-de-Marne
Adverum Clinical Site 600 London United Kingdom
Adverum Clinical Site 601 Oxford United Kingdom

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05536973 on ClinicalTrials.gov ↗ ← All trials in France