Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Surabgene Lomparvovec · 2 trials · 2 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.
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.
| 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 |
| 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. |
| Name | Type | Description |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) | DRUG | subretinal injection |
| Ranibizumab Control | DRUG | intravitreal injection |
| Surabgene Lomparvovec | DRUG | Solution Injection |
| Sham | DRUG | needleless injection without fluid |
| Topical Steroid | DRUG | Topical Drops |
| Artificial Tears | DRUG | Topical Drops |
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...