Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F16%3AN0000190" target="_blank" >RIV/00064173:_____/16:N0000190 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1097/IAE.0000000000001004" target="_blank" >http://dx.doi.org/10.1097/IAE.0000000000001004</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1097/IAE.0000000000001004" target="_blank" >10.1097/IAE.0000000000001004</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study

Popis výsledku v původním jazyce

Purpose: To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated with dexamethasone intravitreal implant (DEX implant). Methods: Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at >= 6-month intervals (seven injections maximum). Results: In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, >= 10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a >= 10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved >= 15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 mm and -106 mm, respectively. Conclusion: DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.

Název v anglickém jazyce

Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study

Popis výsledku anglicky

Purpose: To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated with dexamethasone intravitreal implant (DEX implant). Methods: Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at >= 6-month intervals (seven injections maximum). Results: In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, >= 10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a >= 10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved >= 15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 mm and -106 mm, respectively. Conclusion: DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FF - ORL, oftalmologie, stomatologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Retina

ISSN

0275-004X

e-ISSN

—

Svazek periodika

36

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

1143-1152

Kód UT WoS článku

000377139100028

EID výsledku v databázi Scopus

2-s2.0-84957927695