Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

Overview

About this study

The purpose of this study is to evaluate the long-term safety and efficacy of RGX-314.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Starr, M.D.

Open for enrollment

Contact information:

Jessica Morgan C.O.A.

(507) 293-9689

Morgan.Jessica@mayo.edu

More information

Publications

Publications are currently not available