Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Inclusion Criteria:

1. Age ≥ 50 years and ≤ 89 years

2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated withanti-VEGF

4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.

5. Willing and able to provide written, signed informed consent for this study

6. Participants must have demonstrated a meaningful response to anti-VEGF therapy atstudy entry

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to any causes other than AMD

2. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC

3. Any condition in the investigator's opinion that could limit VA improvement in thestudy eye

4. Active or history of retinal detachment, or current retinal tear that cannot betreated, in the study eye

5. Advanced glaucoma or history of secondary glaucoma in the study eye

6. History of intraocular surgery in the study eye within 12 weeks prior torandomization

7. History of intravitreal therapy in the study eye, such as intravitreal steroidinjection or investigational product, other than anti-VEGF therapy, in the 6 monthsprior to Screening Visit 1

8. Prior treatment with gene therapy

9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attackwithin the past 6 months