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

Running, not enrolling · Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT05536973

Run by

Adverum Biotechnologies, Inc.

People needed

69

Starts

2022-08-23

Expected to finish

2028-08-01

Last updated by the study team

2025-08-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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