Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

Launched by ABBVIE · Jan 14, 2022

Keywords

ClinConnect Summary

This is a long-term, observational follow-up study to check the safety and how well RGX-314 works when given into the eye (in the suprachoroidal space) for neovascular or “wet” age-related macular degeneration (nAMD). It follows people who already took part in a previous RGX-314 trial and received the treatment. Participants enroll after finishing the parent study and will be watched for up to 5 years after their RGX-314 administration, so each person’s time in the study may be different.

Eligible participants include men and women of all ages (including children, adults, and older adults) who were in the original RGX-314 nAMD study, received the injection, and can give informed consent and follow the study plan. The study does not give a new treatment; instead, it observes safety and how long any benefits last, with follow-up at many sites across the United States. Researchers will monitor eye safety (any eye-related problems or serious events), changes in vision (measured as best corrected visual acuity, BCVA), and eye thickness (central retinal thickness, CRT), and they will note whether participants need additional anti-VEGF eye injections or retina clinic visits over the 5-year period. The study is sponsored by AbbVie, overseen by a safety monitoring committee, and is planned to complete primary data collection around 2028.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must provide written, signed informed consent for this study.
• • 2. Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.
• • 3. Must be willing and able to comply with all study procedures.
• Exclusion Criteria:
• • 1. None