Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema
Original language description
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).
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FF - ENT (ie. ear, nose, throat), ophthalmology, dentistry
OECD FORD branch
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Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Ophthalmology
ISSN
0161-6420
e-ISSN
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Volume of the periodical
121
Issue of the periodical within the volume
10
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
1904-1914
UT code for WoS article
000342697300019
EID of the result in the Scopus database
2-s2.0-84908118639