Clinical Trials

Main Observational Study:

Inclusion Criteria:

• Able and willing to provide written consent.
• Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314.

Exclusion Criteria:

• None.

Fellow Eye Substudy:

Inclusion Criteria:

• Age ≤ 93 years.
• Currently or previously enrolled in the main observational study.
• Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration.
• Active nAMD in the fellow eye.
• BCVA between ≤ 80 and ≥ 20 letters in the fellow eye.

Exclusion Criteria:

• CNV or macular edema in the fellow eye secondary to causes other than nAMD.
• Subfoveal fibrosis or atrophy in the fellow eye.
• Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma .
• Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
• History of intraocular surgery in the fellow eye within 12 weeks of screening.
• History of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for nAMD, in the fellow eye within 6 months of screening.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/1/23. Questions regarding updates should be directed to the study team contact.