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

Korábbi kezelés

• Ocular or periocular infection or intraocular inflammation in either eye within 1 month prior to or at the Randomization Visit (Day -7)
• History or evidence of significant uncontrolled concomitant disease within 6 months of the Screening visit
• Prior treatment with photodynamic therapy or retinal laser for the treatment of nAMD
• 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

Más betegség

• 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
• History or evidence of macular or retinal disease other than nAMD
• Uncontrolled ocular hypertension or glaucoma
• Any history of vitrectomy or any other vitreoretinal surgery

Laborértékek

• Uncontrolled diabetes or HbA1c ≥ 7.0 %
• Any history of ongoing bleeding disorders or INR >3.0

Egyéb

• History or evidence of retinal detachment or retinal pigment epithelium rip/tear

• 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)