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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01027650 | Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO) | PHASE1 | COMPLETED | 121 | — | — | Mar 1, 2010 | Feb 1, 2013 | Apr 29, 2014 | 5 | United States, Australia +3 |
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
| Arm | Type | Description |
|---|---|---|
| Stage 1 Cohort 1 | EXPERIMENTAL | AGN208397 intravitreal injection 75 ug on Day 1. |
| Stage 1 Cohort 2 | EXPERIMENTAL | AGN208397 intravitreal injection 300 ug on Day 1. |
| Stage 1 Cohort 3 | EXPERIMENTAL | AGN208397 intravitreal injection 600 ug on Day 1. |
| Stage 1 Cohort 4 | EXPERIMENTAL | AGN208397 intravitreal injection 900 ug on Day 1. |
| Stage 2 Arm 1 | EXPERIMENTAL | AGN208397 intravitreal injection 600 ug on Day 1. |
| Stage 2 Arm 2 | EXPERIMENTAL | AGN208397 intravitreal injection 450 ug on Day 1. |
| Stage 2 Arm 3 | EXPERIMENTAL | AGN208397 intravitreal injection 300 ug on Day 1. |
| Stage 2 Arm 4 | ACTIVE_COMPARATOR | Dexamethasone 700 ug intravitreal implant on Day 1. |
| Name | Type | Description |
|---|---|---|
| AGN208397 intravitreal injection | DRUG | AGN208397 intravitreal injection on Day 1. |
| dexamethasone intravitreal implant | DRUG | Dexamethasone 700 ug intravitreal implant on Day 1. |
Inclusion Criteria: * macular edema due to retinal vein occlusion * visual acuity in the study eye between 20/320 to 20/40 Exclusion Criteria: * cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months) * use of injecta...
| 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 |