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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 DR without center involved-diabetic macular edema (CI-DME) in which they received 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 a total of 5 years post-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 | Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest | 5 years inclusive of the parent study |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography | 5 years, inclusive of the parent study | |
| Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Study population includes participants who received RGX-314 in a parent study of DR without center involved-diabetic macular edema
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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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| 5 years, inclusive to the parent study |
| Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA | 5 years, inclusive to the parent study |
| Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study) | 5 years, inclusive to the parent study |
| Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT | 5 years, inclusive to the parent study |
| Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA | 5 years, inclusive to the parent study |
| Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP) | 5 years, inclusive to the parent study |
| Proportion of participants with any sight-threatening ocular diabetic complications | 5 years, inclusive to the parent study |
| Bakersfield |
| California |
| 93309 |
| United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| American Institute of Research | Los Angeles | California | 90017 | United States |
| Northern California Retina Vitreous Associates Medical Group Inc | Mountain View | California | 94040 | United States |
| California Eye Specialists Medical Group, Inc | Pasadena | California | 91107 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| California Retina Consultants CRC | Santa Barbara | California | 93103 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Sierra eye Associates | Reno | Nevada | 89502 | United States |
| New Jersey Retina | Teaneck | New Jersey | 07666 | United States |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Retinovitreous Associates, LTD | Philadelphia | Pennsylvania | 19107 | United States |
| Charles Retina Institute, P.C | Germantown | Tennessee | 38138 | United States |
| Austin Clinical Research | Austin | Texas | 78750 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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