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This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roll over | No intervention All subjects that previously received RGX-314 in a parent study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. | Other | All subjects that previously received RGX-314 in a parent study |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long-term safety of RGX-314 | Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest | 5 years inclusive of parent study |
| Measure | Description | Time Frame |
|---|---|---|
| • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA) | • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA | 5 years inclusive of parent study |
| • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Exclusion Criteria:
1. None
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The sample sizes were determined by the parent studies and all participants who received an SCS administration of RGX-314 will be invited to participate in the long-term follow-up study. All Enrolled Population: Includes all participants who are enrolled in the long-term follow-up study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | United States | ||
| California Retina Consultants |
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• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT |
| 5 years inclusive of parent study |
| • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy | • Mean number of supplemental anti-VEGF injections based on chart review | 5 years inclusive of parent study |
| • To assess the need of clinic visits for management of nAMD | • Mean number of retina specialist visits attended for nAMD based on chart review | 5 years inclusive of parent study |
| Bakersfield |
| California |
| 93309 |
| United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Northern California Retina Vitreous Associates Medical Group Inc | Mountain View | California | 94040 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Southeast Retina Center PC | Augusta | Georgia | 30909 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Vitreoretinal Surgery PLLC | Edina | Minnesota | 55435 | United States |
| Sierra eye Associates | Reno | Nevada | 89502 | United States |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Retinovitreous Associates, LTD | Philadelphia | Pennsylvania | 19107 | United States |
| Charles Retina Institute, P.C | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |