Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ranibizumab (LUCENTIS®)
Ranibizumab · 5 trials · 4 indications
To evaluate the long-term safety of ABBV-RGX-314
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 |
|---|---|---|
| Standard of Care | OTHER | Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration. |
| Supplemental Treatment | OTHER | DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity. |
| 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 |
|---|---|---|
| Standard of Care | DRUG | Standard of Care |
| Ranibizumab | DRUG | Injection |
| 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: 1. Must provide written, signed informed consent for this study. 2. Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study. 3. Must be willing and able to comply with all...
Ranibizumab is used for the treatment of macular edema, neovascular age-related macular degeneration (nAMD), and choroidal neovascularization. It is a monoclonal antibody being developed by AbbVie Inc. for ophthalmology indications. The drug is currently in Phase 2 clinical trials.
Ranibizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF). By binding to VEGF, it inhibits the growth of abnormal blood vessels in the eye, which is relevant to conditions like neovascular age-related macular degeneration and macular edema.
Ranibizumab is being developed by AbbVie Inc., which is listed on the stock exchange under the ticker ABBV. The drug is also known by the brand name LUCENTIS. It is currently in Phase 2 clinical development for ophthalmology indications.
Ranibizumab is in Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are evaluating its safety and efficacy for conditions such as neovascular age-related macular degeneration and macular edema.
Ranibizumab has been studied in several clinical trials, including NCT00775411 for choroidal neovascularization, NCT01492400 for diabetic macular edema, and NCT04514653 and NCT05210803 for neovascular age-related macular degeneration. These trials are Phase 2 studies with a total enrollment of 363 participants across multiple countries.
Yes, Ranibizumab is the same as LUCENTIS. LUCENTIS is the brand name under which ranibizumab is known. The drug is being developed by AbbVie Inc. for the treatment of eye conditions such as macular edema and neovascular age-related macular degeneration.