Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F14%3AN0000034" target="_blank" >RIV/00064173:_____/14:N0000034 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.ophtha.2014.04.024" target="_blank" >http://dx.doi.org/10.1016/j.ophtha.2014.04.024</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ophtha.2014.04.024" target="_blank" >10.1016/j.ophtha.2014.04.024</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema

Popis výsledku v původním jazyce

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME). Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis. Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of }= 300 mu m by optical coherence tomography. Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at {= 40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of }= 15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP). Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with }= 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P {= 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 mu m) and DEX implant 0.35 mg (-107.9 mu m) than sham (-41.9 mu m; P < 0.001).

Název v anglickém jazyce

Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema

Popis výsledku anglicky

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME). Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis. Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of }= 300 mu m by optical coherence tomography. Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at {= 40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of }= 15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP). Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with }= 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P {= 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 mu m) and DEX implant 0.35 mg (-107.9 mu m) than sham (-41.9 mu m; P < 0.001).

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

2014

Kód důvěrnosti údajů

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

Název periodika

Ophthalmology

ISSN

0161-6420

e-ISSN

—

Svazek periodika

121

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

1904-1914

Kód UT WoS článku

000342697300019

EID výsledku v databázi Scopus

2-s2.0-84908118639