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

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring 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 Read More

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.
• Current evidence of active primary or recurrent sub-foveal choroidal neovascularization (CNV) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
• Subjects must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening
• BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320

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
• History within the 12 months prior to Screening or evidence of renal or hepatic dysfunction at Screening
• Any history of ongoing bleeding disorders or INR >3.0
• History or evidence of macular or retinal disease other than nAMD
• Active or history 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 within 3 months prior to the Randomization Visit (Day -7)
• 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