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ABBV-RGX-314 Dose 1 · 2 trials · 8 indications
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
AEs and SAEs through Week 50
To evaluate the effect of ABBV-RGX-314 on DR by the ETDRS DRSS at Week 48.
To evaluate the effect of ABBV-RGX-314 on BCVA at Week 54.
| Arm | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | EXPERIMENTAL | ABBV-RGX-314 Dose 1 administered via subretinal delivery one time. |
| ABBV-RGX-314 Dose 2 | EXPERIMENTAL | ABBV-RGX-314 Dose 2 administered via subretinal delivery one time. |
| Control Arm | ACTIVE_COMPARATOR | Aflibercept administered via intravitreal injection approximately every 8 weeks |
| Part 1: Observation Control Arm | NO_INTERVENTION | Observation Control |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | ABBV-RGX-314 Dose 1 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 2) | EXPERIMENTAL | ABBV-RGX-314 Dose 2 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Topical Steroid |
| Part 2: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 4 and Topical Steroid |
| Part 2: Aflibercept Control | ACTIVE_COMPARATOR | Control treatment arm |
| Name | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| ABBV-RGX-314 Dose 2 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2) |
| Aflibercept (EYLEA®) | BIOLOGICAL | 2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| Topical Steroid | DRUG | Topical Steroid |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
| Aflibercept | BIOLOGICAL | Aflibercept |
Inclusion Criteria: 1. Age ≥ 50 years and ≤ 89 years 2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye 3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postc...
ABBV-RGX-314 Dose 1 is an investigational gene therapy in Phase 3 development for the treatment of age-related macular degeneration (AMD) and diabetic retinopathy (DR). It is being studied in patients with wet AMD and diabetic retinopathy with or without center-involved diabetic macular edema.
ABBV-RGX-314 Dose 1 is a gene therapy designed to deliver a gene that encodes for an anti-angiogenic protein. It is administered in the suprachoroidal space to target the underlying cause of retinal diseases like AMD and diabetic retinopathy, potentially reducing the need for frequent injections.
ABBV-RGX-314 Dose 1 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 3 clinical trials for ophthalmology indications.
ABBV-RGX-314 Dose 1 is in Phase 3 clinical development. It is an investigational gene therapy and has not been approved by regulatory authorities. The drug is being evaluated in active clinical trials for AMD and diabetic retinopathy.
ABBV-RGX-314 Dose 1 is being studied in two active clinical trials. NCT04567550 is a Phase 2 trial in diabetic retinopathy with 139 participants, and NCT05407636 is a Phase 3 pivotal trial in wet AMD with 735 participants. Both trials are active but not recruiting.
ABBV-RGX-314 Dose 1 is a specific dose of RGX-314, a gene therapy being developed by AbbVie. The trials listed under ABBV-RGX-314 Dose 1 evaluate RGX-314 administered in the suprachoroidal space for retinal diseases.