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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04418427 | ADVM-022 Intravitreal Gene Therapy for DME | PHASE2 | COMPLETED | 36 | — | — | May 28, 2020 | Jun 14, 2023 | Jul 10, 2025 | 14 | United States, Puerto Rico |
Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST \> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
| 2 | EXPERIMENTAL | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
| 3 | ACTIVE_COMPARATOR | Aflibercept 2mg IVT |
| Name | Type | Description |
|---|---|---|
| 6E11 vg/eye of ADVM-022 | BIOLOGICAL | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
| 2E11 vg/eye of ADVM-022 | BIOLOGICAL | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
| Aflibercept | BIOLOGICAL | Commercially available Active Comparator |
Inclusion Criteria: * Age ≥ 18 * Type 1 or Type 2 diabetes mellitus * Willing and able to provide informed consent * Vision impairment due to center involving diabetic macular edema Exclusion Criteria: * Uncontrolled diabetes defined as HbA1C \>10%, or history of diabetic ketoacidosis within 3 mo...
| 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 |