Intravitreal Celecoxib for Chronic Uveitis
Keywords
Coimriú
Cur síos
Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.
II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.
After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.
Dátaí
| Fíoraithe Deireanach: | 01/31/2017 |
| Cuireadh isteach den chéad uair: | 04/30/2014 |
| Clárú Measta Curtha isteach: | 04/30/2014 |
| Arna chur suas ar dtús: | 05/05/2014 |
| Nuashonrú Deireanach Curtha isteach: | 02/19/2017 |
| Nuashonrú Deireanach Postáilte: | 02/22/2017 |
| Dáta Tosaigh an Staidéir Iarbhír: | 05/31/2015 |
| Dáta Críochnaithe Bunscoile Measta: | 10/31/2016 |
| Dáta Críochnaithe an Staid Mheasta: | 10/31/2016 |
Coinníoll nó galar
Idirghabháil / cóireáil
Drug: Celecoxib
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| Experimental: Celecoxib 1-4 mg intravitreal injection ofCelecoxib | Drug: Celecoxib 1-4 mg intravitreal celecoxib |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 15 Years Chun 15 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | Inclusion Criteria: - Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects Exclusion Criteria: - 15 years or younger Have active ocular infection Pregnancy Phakic subjects |
Toradh
Bearta Toraidh Príomhúla
1. Safety [12 weeks]
Bearta Torthaí Tánaisteacha
1. Efficacy [12 weeks]
