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

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 aminimum of 2 injections within 4 months prior to screening for the treatment ofchoroidal 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 (approximateSnellen equivalent of 20/200 or better)

Exclusion Criteria:

• Any condition that could affect the interpretation of results or render theparticipant at high risk of treatment complications in the opinion of theInvestigator

• Ocular or periocular infection or intraocular inflammation in either eye within 1month 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 monthsof 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 therapyinvestigational treatment or medical device in the study eye within 3 months of theScreening Visit or 5 half-lives of the investigational medicinal product