Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-RGX-314, surabgene lomparvovec, ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2
RGX-314 · 8 trials · 15 indications
To assess the injection burden and the necessity for supplemental anti-VEGF injections over the first year of the study period across the different treatment groups.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of participants who experience intraocular inflammation.
Percentage of participants who experience scleral inflammation including episcleritis.
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.
The scale used is the early treatment diabetic retinopathy study (ETDRS) letter score from 0-100 and higher score being better vision.
| Arm | Type | Description |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 | EXPERIMENTAL | Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time. |
| Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 | EXPERIMENTAL | Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time. |
| Ranibizumab Control Group | EXPERIMENTAL | Ranibizumab administered via intravitreal injection as needed PRN |
| 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 |
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A | EXPERIMENTAL | Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A. |
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B | EXPERIMENTAL | Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B. |
| Phase 2b: Sham + Artificial Tears -Regimen A | PLACEBO_COMPARATOR | Participants will receive a single injection of sham+ artificial tears -Regimen A. |
| Phase 2b: Sham + Artificial Tears -Regimen B | PLACEBO_COMPARATOR | Participants will receive a single injection of Sham+ artificial tears -Regimen B. |
| Phase 3: Surabgene Lomparvovec + Steroid | EXPERIMENTAL | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid |
| Phase 3: Sham + Artificial Tears | PLACEBO_COMPARATOR | Participants will receive a single injection of Sham + artificial tears. |
| Bilateral: B1-Surabgene Lomparvovec + Steroid | EXPERIMENTAL | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye. |
| Bilateral: B2-Surabgene Lomparvovec + Steroid | EXPERIMENTAL | Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye. |
| Commercial Formulation Dose 1 | EXPERIMENTAL | Dose 1 of RGX-314 |
| Clinical Formulation Dose 1 | EXPERIMENTAL | Dose 1 of RGX-314 |
| Commercial Formulation Dose 2 | EXPERIMENTAL | Dose 2 of RGX-314 |
| Clinical Formulation Dose 2 | EXPERIMENTAL | Dose 2 of RGX-314 |
| 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 |
| 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 |
| Main Observational Study | NO_INTERVENTION | All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm. |
| RGX-314 Fellow Eye Treatment Substudy | EXPERIMENTAL | RGX-314 Fellow Eye Treatment |
| Name | Type | Description |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) | DRUG | subretinal injection |
| Ranibizumab Control | DRUG | intravitreal 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) |
| Aflibercept (EYLEA®) | BIOLOGICAL | 2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections |
| Surabgene Lomparvovec | DRUG | Solution Injection |
| Sham | DRUG | needleless injection without fluid |
| Topical Steroid | DRUG | Topical Drops |
| Artificial Tears | DRUG | Topical Drops |
| RGX-314 | GENETIC | RGX-314 is a recombinant adeno-associated virus gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein |
| ABBV-RGX-314 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| Ranibizumab (LUCENTIS®) | BIOLOGICAL | 0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
| Aflibercept | BIOLOGICAL | Aflibercept |
| Ranibizumab | BIOLOGICAL | Ranibizumab (anti-VEGF agent) |
| Local Steroid | DRUG | Local steroid |
Inclusion Criteria: * Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye. * Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion characteristics as asses...
RGX-314 is an investigational gene therapy being developed for neovascular age-related macular degeneration (nAMD), also known as wet macular degeneration. It is designed to treat this condition, which causes abnormal blood vessel growth and leakage in the retina, leading to vision loss.
RGX-314 is a gene therapy intended to treat neovascular age-related macular degeneration. It works by delivering a gene that encodes for an anti-angiogenic protein, which inhibits the growth of abnormal blood vessels in the eye. This mechanism aims to reduce vascular leakage and preserve vision.
RGX-314 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the therapy for neovascular age-related macular degeneration.
RGX-314 is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing trials are evaluating its safety and efficacy for neovascular age-related macular degeneration.
RGX-314 has two Phase 2 clinical trials. NCT03999801 is a long-term follow-up study with 865 participants, currently enrolling by invitation. NCT04832724 is a completed pharmacodynamic study with 60 participants. Both trials are conducted in the United States for neovascular age-related macular degeneration.
RGX-314 is a gene therapy specifically developed for neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. It is not the same as existing treatments but is designed to address the underlying cause of the condition by providing long-term expression of an anti-angiogenic protein.