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

Launched by ABBVIE · Jun 24, 2019

Keywords

ClinConnect Summary

This study is a long-term follow-up of people who previously received RGX-314, a gene therapy given as a subretinal injection to treat wet age-related macular degeneration (nAMD). The researchers want to see how safe this treatment is and how well it works over up to 5 years after the first dose. There’s also a fellow-eye substudy for people with disease in both eyes, where the other eye may receive RGX-314 as well. They will track eye safety, changes in vision, retinal thickness, how many extra eye injections are needed, and how often participants visit eye doctors.

Who can participate? Adults aged 50 and older who previously took part in the RGX-314 parent study can enroll. The fellow-eye substudy has its own criteria and involves receiving RGX-314 in the other eye and following a 54-week visit schedule. The study is not randomized and does not use masking, and it is overseen for safety by a data monitoring committee and regulated as a drug trial by the FDA. It is sponsored by AbbVie and is enrolling by invitation at multiple U.S. sites, aiming for about 865 participants with completion expected around 2028.

Gender

ALL

Eligibility criteria

• Main Observational Study:
• Inclusion Criteria:
• • 1. Able and willing to provide written consent
• • 2. Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314
• Exclusions Criteria:
• • 1. None
• Fellow Eye Substudy:
• • Inclusion Criteria
• • 1. Age ≤ 93 years
• • 2. Currently or previously enrolled in the main observational study
• • 3. Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration
• • 4. Active nAMD in the fellow eye
• • 5. BCVA between ≤ 80 and ≥ 20 letters in the fellow eye
• Exclusion Criteria:
• • 1. CNV or macular edema in the fellow eye secondary to causes other than nAMD
• • 2. Subfoveal fibrosis or atrophy in the fellow eye
• • 3. Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma
• • 4. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
• • 5. History of intraocular surgery in the fellow eye within 12 weeks of screening
• • 6. 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