Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ranibizumab · 4 trials · 4 indications
The scale used is the early treatment diabetic retinopathy study (ETDRS) letter score from 0-100 and higher score being better vision.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
| Arm | Type | Description |
|---|---|---|
| Ranibizumab control | ACTIVE_COMPARATOR | Control treatment arm |
| ABBV-RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | ABBV-RGX-314 Dose 1 |
| ABBV-RGX-314 Treatment Arm (Dose 2) | EXPERIMENTAL | ABBV-RGX-314 Dose 2 |
| ABBV-RGX-314 Treatment Arm (Dose 3) | EXPERIMENTAL | ABBV-RGX-314 Dose 3 |
| ABBV-RGX-314 Treatment Arm (Dose 3) and Local Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Local Steroid |
| ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Topical Steroid |
| ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 4 and Topical Steroid |
| dexamethasone Intravitreal Implant | EXPERIMENTAL | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| ranibizumab | ACTIVE_COMPARATOR | Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. |
| 700 µg dexamethasone and ranibizumab | EXPERIMENTAL | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. |
| dexamethasone and ranibizumab | EXPERIMENTAL | Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. |
| sham and ranibizumab | SHAM_COMPARATOR | Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. |
| Name | Type | Description |
|---|---|---|
| Ranibizumab | BIOLOGICAL | Ranibizumab (anti-VEGF agent) |
| 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) |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| Local Steroid | DRUG | Local steroid |
| Topical Steroid | DRUG | Topical steroid |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
| dexamethasone Intravitreal Implant | DRUG | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| dexamethasone | DRUG | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. |
| sham | OTHER | Sham needle-less injection administered in the study eye at Day 1. |
Inclusion Criteria: * Age \>/= 50 and \</= 89 * Diagnosis of CNV secondary to age-related macular degeneration in the study eye. * Participants must have demonstrated a meaningful response to anti-VEGF therapy. * Willing and able to provide written, signed informed consent for this study. Exclusio...