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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 in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.
Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Observational Study | No Intervention | All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm. | |
| RGX-314 Fellow Eye Treatment Substudy | Experimental | RGX-314 Fellow Eye Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGX-314 | Genetic | AAV8 vector containing a transgene for anti-VEGF Fab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular adverse events and any serious adverse events in the study eye | 5 years inclusive of parent study | |
| Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in best corrected visual acuity (BCVA) in the study eye | Mean change and proportion of participants losing greater than or equal to 5, 10, and 15 letters | 5 years inclusive of parent study |
| Change from baseline in Central Retinal Thickness (CRT) in the study eye |
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Main Observational Study:
Inclusion Criteria:
Exclusions Criteria:
1. None
Fellow Eye Substudy:
Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LCC | Phoenix | Arizona | 85053 | United States | ||
| California Retina Consultants CRC |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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1 main Observational study arm, 1 RGX-314 Fellow Eye Treatment substudy
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Mean change from baseline in CRT as measured by spectral domain optical coherence tomography (SD-OCT) |
| 5 years inclusive of parent study |
| Number of supplemental anti-VEGF injections in the study eye | Mean number of supplemental anti-VEGF injections based on chart review | 5 years inclusive of parent study |
| Number of retinal specialist visits for the study eye | Mean number of retinal specialist visits attended for nAMD based on chart review | 5 years inclusive of parent study |
| Fellow eye substudy: Change from baseline in best corrected visual acuity | Mean change from baseline in BCVA in the fellow eye | 54 weeks |
| Fellow eye substudy: Change from baseline in Central Retinal Thickness in the fellow eye | Mean change from baseline in CRT in the fellow eye as measured by SD-OCT | 54 weeks |
| Fellow eye substudy: Number of supplemental anti-VEGF injections in the fellow eye | Mean number of supplemental anti-VEGF injections in the fellow eye | 54 weeks |
| Fellow eye substudy: Aqueous and Serum RGX-314 transgene product (TP) concentrations in the fellow eye | Fellow eye aqueous and serum RGX-314 TP concentrations at assessed time points | 54 weeks |
| Fellow eye substudy: Immunogenicity measurements in the fellow eye | Fellow eye immunogenicity measurements at assessed timepoints | 54 weeks |
| Santa Barbara |
| California |
| 93103 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| University of Pennsylvania Department of Ophthalmology | Philadelphia | Pennsylvania | 19104 | United States |
| MidAtlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Retina Consultants of Texas Research Center | The Woodlands | Texas | 77384 | United States |