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| Name | Class |
|---|---|
| REGENXBIO Inc. | INDUSTRY |
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Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
This Phase 2 trial is an open label, randomized, active controlled, dose-ranging trial to allow for preliminary safety and efficacy data on subretinal (SR) delivery of RGX-314 in participants with CI - DME
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGX-314 Treatment Arm (Dose 1) | Experimental | Genetic: RGX-314 Dose 1 - AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
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| Treatment Arm (Dose 2) | Experimental | Genetic: RGX-314 Dose 2 -AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
|
| Aflibercept Treatment Arm | Active Comparator | Biological: Aflibercept IVT
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGX-314 Dose 1 | Genetic | AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA in the study eye at Week 52 | To evaluate the effect of RGX-314 on BCVA at Week 52 | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA in the study eye over time | To evaluate the effect of RGX-314 on BCVA over time | 52 Weeks |
| Proportion of participants with BCVA of 20/40 or better (ETDRS ≥ 69 letters) in the study eye over time |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Study Coordinator | Contact | 775-329-0286 | jvannavong@sierraeyeassociates.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Eye Associates | Recruiting | Reno | Nevada | 89502 | United States |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| RGX-314 Dose 2 | Genetic | AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
|
| Aflibercept (2.0 mg) | Biological | Commercially available Active Comparator |
|
To evaluate the effect of RGX-314 on BCVA over time
| 52 Weeks |
| Mean change from baseline in central subfield thickness (CST) in the study at week 52 | To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52 | 52 Weeks |
| Mean change from baseline in CST in the study eye on SD-OCT at Week 26 and Week 52 | To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52 | 52 Weeks |
| Proportion of participants with an absence of CI-DME in the study eye at Week 26 and Week 52 | To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52 | 52 Weeks |
| Proportion of participants achieving a 2-step or greater improvement or any improvement (a 1-step or greater improvement) in DR in the study eye by ETDRS DRSS on 4 widefield digital stereoscopic fundus photography at Week 52 | To evaluate the effect of RGX-314 on DR by the ETDRS DRSS at Week 52 | 52 Weeks |
| Incidences of overall and ocular adverse events (AEs) | To assess the safety and tolerability of RGX-314 | 52 Weeks |
| Proportion of participants requiring any additional intervention for ocular diabetic complications to Week 52 | To evaluate the need for additional standard of care intervention due to ocular diabetic complications | 52 Weeks |
| Proportion of participants with any sight-threatening ocular diabetic complications to Week 52 | To evaluate the need for additional standard of care intervention due to ocular diabetic complications | 52 Weeks |
| Proportion of participants developing ocular diabetic complications requiring treatment per standard of care (anti-VEGF treatment, steroid treatment, pan retinal photocoagulation, laser, or surgery) through Week 52 | To evaluate the need for additional standard of care intervention due to ocular diabetic complications | 52 Weeks |
| Proportion of participants developing ocular diabetic complications (e.g., neovascularization due to DR) requiring treatment per standard of care (pan retinal photocoagulation or anti-VEGF treatment) through Week 52 | To evaluate the need for additional standard of care intervention due to ocular diabetic complications | 52 Weeks |
| Proportion of participants developing ocular diabetic complications (e.g., retinal detachments) requiring surgical intervention per standard of care through Week 52 | To evaluate the need for additional standard of care intervention due to ocular diabetic complications | 52 Weeks |
| Aqueous RGX-314 transgene (TP) concentration at assessed time points | To measure aqueous RGX-314 TP concentrations | 52 Weeks |
| Proportion of participants with visual stability in the study eye from baseline to Week 52 | To evaluate the effect of RGX-314 on vision outcomes | 52 Weeks |
| Proportion of participants with vision gain or vision loss ≥ to 5, 10, or 15 ETDRS letters in the study eye from baseline to Week 52 | To evaluate the effect of RGX-314 on vision outcomes | 52 Weeks |