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AGN208397 intravitreal · 1 trial · 2 indications
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 |
AGN208397 intravitreal is an investigational small molecule being developed for the treatment of macular edema, specifically macular edema associated with retinal vein occlusion (RVO). It is administered intravitreally and is currently in Phase 1 clinical development.
AGN208397 intravitreal is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for macular edema associated with retinal vein occlusion.
AGN208397 intravitreal is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under investigation for macular edema associated with retinal vein occlusion.
AGN208397 intravitreal has been studied in one completed Phase 1 clinical trial, NCT01027650, which evaluated its safety and efficacy in treating macular edema associated with retinal vein occlusion. The trial enrolled 121 participants across the United States, Australia, Canada, Israel, and South Africa.
AGN208397 intravitreal is the specific name used in clinical development for this investigational treatment. No alternative names have been established for this drug in the available information.