Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis.
Details
Serval ID
serval:BIB_E55516348930
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis.
Journal
Archives of Ophthalmology
Working group(s)
Ozurdex HURON Study Group
Contributor(s)
Belfort , Cui , Foster , Li , Lightman , Lowder , Robinson , Schiffman , Augusto Moreira C., Whitcup , Belfort , Barisani-Asenbauer T., Neto J., Biswas J., Brezin A., Callanan D., Cassoux N., DeBarge L., Deschenes J., Diaz-Rohena R., Ephraim G., Feuermannová A., Forrester J., Garg S., Goldstein M., Guex-Crosier Y., Kramer M., Lee S., Lightman , Lowder , Mackensen F., Markomichelakis N., Merrill P., Nussenblatt R., Palestine A., Pleyer U., Proenca R., Sheppard J., Shneck M., Raczynska K., Rabinovitch T., Rathinam S., Rihov E., de la Maza M., Samson C., Sangwan V., Sartani G., Stanford M., Tay Kearney M., Tessler H., Teitelbaum C., Thorne J., Vieira de Moraes H., Vishnevskia-Dai V., Wang R.
ISSN
1538-3601 (Electronic)
ISSN-L
0003-9950
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
129
Number
5
Pages
545-553
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
OBJECTIVE: To evaluate the safety and efficacy of 2 doses of dexamethasone intravitreal implant (DEX implant) for treatment of noninfectious intermediate or posterior uveitis.
METHODS: In this 26-week trial, eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with a 0.7-mg DEX implant (n = 77), 0.35-mg DEX implant (n = 76), or sham procedure (n = 76).
MAIN OUTCOME MEASURE: The main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8.
RESULTS: The proportion of eyes with a vitreous haze score of 0 at week 8 was 47% with the 0.7-mg DEX implant, 36% with the 0.35-mg DEX implant, and 12% with the sham (P < .001); this benefit persisted through week 26. A gain of 15 or more letters from baseline best-corrected visual acuity was seen in significantly more eyes in the DEX implant groups than the sham group at all study visits. The percentage of eyes with intraocular pressure of 25 mm Hg or more peaked at 7.1% for the 0.7-mg DEX implant, 8.7% for the 0.35-mg DEX implant, and 4.2% for the sham (P > .05 at any visit). The incidence of cataract reported in the phakic eyes was 9 of 62 (15%) with the 0.7-mg DEX implant, 6 of 51 (12%) with the 0.35-mg DEX implant, and 4 of 55 (7%) with the sham (P > .05).
CONCLUSIONS: In patients with noninfectious intermediate or posterior uveitis, a single DEX implant significantly improved intraocular inflammation and visual acuity persisting for 6 months. Application to Clinical Practice Dexamethasone intravitreal implant may be used safely and effectively for treatment of intermediate and posterior uveitis. Trial Registration clinicaltrials.gov Identifier: NCT00333814.
METHODS: In this 26-week trial, eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with a 0.7-mg DEX implant (n = 77), 0.35-mg DEX implant (n = 76), or sham procedure (n = 76).
MAIN OUTCOME MEASURE: The main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8.
RESULTS: The proportion of eyes with a vitreous haze score of 0 at week 8 was 47% with the 0.7-mg DEX implant, 36% with the 0.35-mg DEX implant, and 12% with the sham (P < .001); this benefit persisted through week 26. A gain of 15 or more letters from baseline best-corrected visual acuity was seen in significantly more eyes in the DEX implant groups than the sham group at all study visits. The percentage of eyes with intraocular pressure of 25 mm Hg or more peaked at 7.1% for the 0.7-mg DEX implant, 8.7% for the 0.35-mg DEX implant, and 4.2% for the sham (P > .05 at any visit). The incidence of cataract reported in the phakic eyes was 9 of 62 (15%) with the 0.7-mg DEX implant, 6 of 51 (12%) with the 0.35-mg DEX implant, and 4 of 55 (7%) with the sham (P > .05).
CONCLUSIONS: In patients with noninfectious intermediate or posterior uveitis, a single DEX implant significantly improved intraocular inflammation and visual acuity persisting for 6 months. Application to Clinical Practice Dexamethasone intravitreal implant may be used safely and effectively for treatment of intermediate and posterior uveitis. Trial Registration clinicaltrials.gov Identifier: NCT00333814.
Keywords
Adult, Cataract/chemically induced, Dexamethasone/administration & dosage, Dexamethasone/adverse effects, Double-Blind Method, Drug Implants, Eye Infections/drug therapy, Female, Glucocorticoids/administration & dosage, Glucocorticoids/adverse effects, Humans, Intraocular Pressure/drug effects, Male, Middle Aged, Prospective Studies, Treatment Outcome, Uveitis, Intermediate/drug therapy, Uveitis, Posterior/drug therapy, Visual Acuity/drug effects, Vitreous Body
Pubmed
Web of science
Create date
18/11/2011 10:21
Last modification date
20/08/2019 16:08
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