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Also known as dexamethasone Intravitreal Implant
dexamethasone Intravitreal · 1 trial · 1 indication
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| dexamethasone Intravitreal Implant | EXPERIMENTAL | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| ranibizumab | ACTIVE_COMPARATOR | Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. |
| Name | Type | Description |
|---|---|---|
| dexamethasone Intravitreal Implant | DRUG | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| ranibizumab | DRUG | Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. |
Inclusion Criteria: * Diagnosis of type 1 or 2 diabetes mellitus * Diagnosis of macular edema * Visual acuity between 20/200 to 20/40 Exclusion Criteria: * Eye surgery to the study eye within 3 months * Use of Ozurdex® within 9 months * Any active ocular inflammation and infection * Diagnosis of ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
Dexamethasone intravitreal is an investigational small-molecule corticosteroid formulation delivered into the vitreous of the eye. It is being studied in macular edema, including diabetic macular edema, and is also known as the dexamethasone intravitreal implant. It is in Phase 2 clinical development.
Dexamethasone intravitreal targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. Binding of the glucocorticoid receptor is the mechanism through which dexamethasone exerts its corticosteroid activity in the eye.
Dexamethasone intravitreal is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development program for this investigational corticosteroid formulation in macular edema.
Dexamethasone intravitreal is in Phase 2 clinical development. It is investigational and has not been established as approved for use; the recorded clinical work consists of one completed Phase 2 trial in macular edema.
Dexamethasone intravitreal has been studied in trial NCT01492400, a completed Phase 2 safety and efficacy study comparing dexamethasone with ranibizumab in patients with diabetic macular edema. The randomized, active-controlled trial enrolled 363 patients aged 18 years and older across the United States, Belgium, Denmark, France, Germany, Israel, Italy, the Netherlands, Portugal, South Africa, Spain, and the United Kingdom.
Yes. Dexamethasone intravitreal, dexamethasone Intravitreal Implant, and dexamethasone intravitreal implant refer to the same product, an investigational corticosteroid formulation administered into the eye. Readers searching any of these names are looking at the same Phase 2 macular edema program from AbbVie.