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Also known as RGX-314 Dose 1
RGX-314 · 2 trials · 3 indications
To evaluate the effect of RGX-314 on BCVA at Week 52
Participants with ocular and non-ocular AEs and SAEs through 26 weeks (24 weeks following RGX-314 administration)
| Arm | Type | Description |
|---|---|---|
| RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | Genetic: RGX-314 Dose 1 \- AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
| Treatment Arm (Dose 2) | EXPERIMENTAL | Genetic: RGX-314 Dose 2 -AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
| Aflibercept Treatment Arm | ACTIVE_COMPARATOR | Biological: Aflibercept IVT * Commercially available Active Comparator * Other Names: Eylea |
| Cohort 1 | EXPERIMENTAL | 3E9 GC (genome copies)/eye of RGX-314 (E means the exponential constant) |
| Cohort 2 | EXPERIMENTAL | 1E10 GC/eye of RGX-314 |
| Cohort 3 | EXPERIMENTAL | 6E10 GC/eye of RGX-314 |
| Cohort 4 | EXPERIMENTAL | 1.6E11 GC/eye of RGX-314 |
| Cohort 5 | EXPERIMENTAL | 2.5E11 GC/eye of RGX-314 |
| Name | Type | Description |
|---|---|---|
| RGX-314 Dose 1 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
| RGX-314 Dose 2 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
| Aflibercept (2.0 mg) | BIOLOGICAL | Commercially available Active Comparator |
| RGX-314 | GENETIC | RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein |
Inclusion Criteria: * Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment * HbA1c ≤12% * BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening * Decreased visual acuity attributable primarily due to CI - DME * Demonstrate clin...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
RGX-314 is an investigational gene therapy developed by REGENXBIO Inc. for retinal diseases. It is being studied in diabetic macular edema and neovascular age-related macular degeneration, also known as wet AMD. It is not yet approved and remains in clinical development.
RGX-314 is being evaluated for center-involved diabetic macular edema, a form of DME in which fluid accumulates in the central retina. A Phase 2 trial, NCT06942520, is recruiting adults aged 25 and older in the United States to study the therapy in this indication.
RGX-314 is developed by REGENXBIO Inc., a biotechnology company whose common stock trades on Nasdaq under the ticker symbol RGNX. REGENXBIO is the sponsor of the clinical programs evaluating RGX-314 in retinal disease.
RGX-314 is in Phase 2 clinical development. A Phase 2 trial in center-involved diabetic macular edema is currently recruiting, while an earlier Phase 1 study in neovascular age-related macular degeneration has been completed. RGX-314 is investigational and has not been approved by the FDA.
RGX-314 has been studied in two registered trials. NCT06942520 is a recruiting Phase 2 trial in center-involved diabetic macular edema with an enrollment of 18. NCT03066258 was a completed Phase 1 safety and tolerability trial in neovascular AMD that enrolled 42 participants.
Yes. RGX-314 Dose 1 is an alternative name used for RGX-314, the investigational gene therapy from REGENXBIO. Searches for either name refer to the same clinical program in diabetic macular edema and neovascular age-related macular degeneration.