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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01660802 | Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) | PHASE3 | COMPLETED | 262 | — | — | Sep 4, 2012 | May 20, 2014 | Apr 17, 2019 | 1 | China |
| NCT00168298 | A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion | PHASE3 | COMPLETED | 668 | — | — | Nov 1, 2004 | Sep 5, 2008 | Apr 23, 2019 | 13 | United States, Brazil +11 |
| NCT00168324 | A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion | PHASE3 | COMPLETED | 599 | — | — | Oct 1, 2004 | Oct 1, 2008 | Apr 23, 2019 | 13 | United States, Australia +11 |
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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
| Arm | Type | Description |
|---|---|---|
| 700 μg Dexamethasone | EXPERIMENTAL | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Sham | SHAM_COMPARATOR | Sham administered in the study eye on Day 1. |
| 700 µg Dexamethasone | EXPERIMENTAL | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
| 350 µg Dexamethasone followed by 700 µg Dexamethasone | EXPERIMENTAL | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Sham Injection followed by 700 µg Dexamethasone | SHAM_COMPARATOR | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Name | Type | Description |
|---|---|---|
| 700 μg Dexamethasone | DRUG | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Sham | OTHER | Sham administered in the study eye on Day 1. |
| 700 µg Dexamethasone | DRUG | 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. |
| 350 µg Dexamethasone | DRUG | 350 µg Dexamethasone intravitreal implant administered on Day 0. |
| Sham Injection | OTHER | Sham injection on Day 0. |
Inclusion Criteria: -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Exclusion Criteria: * History of glaucoma, ocular hypertension or optic nerve head change * Any acti...
| 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 |