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

Launched by ABBVIE · Jun 24, 2019

Keywords

ClinConnect Summary

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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