Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Surabgene Lomparvovec (ABBV-RGX-314)
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...
Surabgene Lomparvovec is an investigational gene therapy being studied for diabetic retinopathy and neovascular age-related macular degeneration (nAMD). It is administered in the suprachoroidal space and is currently in Phase 2 clinical development for diabetic retinopathy, with a Phase 3 trial recruiting for nAMD.
Surabgene Lomparvovec is a gene therapy that works by delivering a gene to target cells. It is being studied for its potential to reduce injection burden and preserve visual acuity in patients with retinal diseases. The specific molecular target is not disclosed in available clinical trial information.
Surabgene Lomparvovec is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the therapy for diabetic retinopathy and neovascular age-related macular degeneration.
Surabgene Lomparvovec is in Phase 2 clinical development for diabetic retinopathy. A Phase 3 trial is also recruiting for neovascular age-related macular degeneration, indicating the program has advanced to later-stage testing for that indication.
Surabgene Lomparvovec is being studied in two trials. NCT07007065 is a Phase 3 study in neovascular age-related macular degeneration with 561 participants. NCT07592273 is a Phase 2 study in diabetic retinopathy with 576 participants. Both trials are currently recruiting.
Yes, Surabgene Lomparvovec is also known as ABBV-RGX-314. The drug is being developed by AbbVie and is in clinical trials for diabetic retinopathy and neovascular age-related macular degeneration.