Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06942520 | Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME) | PHASE2 | RECRUITING | 18 | — | — | Mar 18, 2025 | Dec 1, 2027 | Apr 24, 2025 | 1 | United States |
To evaluate the effect of RGX-314 on BCVA at Week 52
| 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 |
| 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 |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | — | ADVM-022 |