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Article: Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion

TitleRandomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion
Authors
Issue Date2010
PublisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/ophtha
Citation
Ophthalmology, 2010, v. 117 n. 6, p. 1134-1146.e3 How to Cite?
AbstractOBJECTIVE: To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). DESIGN: Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO). PARTICIPANTS: A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO. INTERVENTION: A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426). MAIN OUTCOME MEASURES: The primary outcome measure for the pooled data from the 2 studies was time to achieve a > or =15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety. RESULTS: After a single administration, the time to achieve a > or =15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P<0.001). The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P<0.001). The percentage of eyes with a > or =15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P< or =0.036). Improvement in mean BCVA was greater in both DEX implant groups compared with sham at all follow-up visits (P< or =0.006). Improvements in BCVA with DEX implant were seen in patients with BRVO and patients with CRVO, although the patterns of response differed. The percentage of DEX implant-treated eyes with intraocular pressure (IOP) of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery. CONCLUSIONS: Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.
DescriptionWico Lai is one of the authors of the Ozurdex Geneva Study Group
Persistent Identifierhttp://hdl.handle.net/10722/127671
ISSN
2015 Impact Factor: 6.75
2015 SCImago Journal Rankings: 4.745
ISI Accession Number ID
Funding AgencyGrant Number
Alimera
Allergan
Genetech
Regeneron
Allergan, Inc.
Funding Information:

The author(s) have made the following disclosure(s): Dr. Haller is a consultant with Genentech and Allergan and an equity owner with Macusight and OptiMedica. Dr. Bandello is a consultant and lecturer with Allergan and Novartis. Dr. Belfort is a consultant and lecturer with Allergan and Alcon. Dr. Blumenkranz is a consultant with Allergan, Macusight, and Genentech, an equity owner with Macusight and Optimedica, a lecturer with Allergan, and a patent holder with Optimedica. Dr. Gillies is a consultant with Allergan, Novartis, and Pfizer. Dr. Heier is a consultant for and received financial support from Alimera, Allergan, Genetech, and Regeneron, and is a lecturer for Regeneron. Dr. Lowenstein is a consultant for Allergan and Notal Vision and a lecturer for Novartis and Alcon. Dr. Yoon is a consultant for Allergan and a lecturer for Alcon. Drs. Jacques, Jiao, Li, and Whitcup are employees of Allergan, Inc.

 

DC FieldValueLanguage
dc.contributor.authorHaller, JAen_HK
dc.contributor.authorBandello, Fen_HK
dc.contributor.authorBelfort, R-
dc.contributor.authorBlumenkranz, MS-
dc.contributor.authorGillies, M-
dc.contributor.authorHeier, J-
dc.contributor.authorLoewenstein, A-
dc.contributor.authorYoon, YH-
dc.contributor.authorJacques, ML-
dc.contributor.authorJiao, J-
dc.contributor.authorLi, XY-
dc.contributor.authorWhitcup, MD-
dc.contributor.authorOZURDEX GENEVA Study Group-
dc.contributor.authorLai, W-
dc.date.accessioned2010-10-31T13:39:18Z-
dc.date.available2010-10-31T13:39:18Z-
dc.date.issued2010en_HK
dc.identifier.citationOphthalmology, 2010, v. 117 n. 6, p. 1134-1146.e3en_HK
dc.identifier.issn0161-6420en_HK
dc.identifier.urihttp://hdl.handle.net/10722/127671-
dc.descriptionWico Lai is one of the authors of the Ozurdex Geneva Study Group-
dc.description.abstractOBJECTIVE: To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). DESIGN: Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO). PARTICIPANTS: A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO. INTERVENTION: A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426). MAIN OUTCOME MEASURES: The primary outcome measure for the pooled data from the 2 studies was time to achieve a > or =15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety. RESULTS: After a single administration, the time to achieve a > or =15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P<0.001). The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P<0.001). The percentage of eyes with a > or =15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P< or =0.036). Improvement in mean BCVA was greater in both DEX implant groups compared with sham at all follow-up visits (P< or =0.006). Improvements in BCVA with DEX implant were seen in patients with BRVO and patients with CRVO, although the patterns of response differed. The percentage of DEX implant-treated eyes with intraocular pressure (IOP) of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery. CONCLUSIONS: Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.-
dc.languageengen_HK
dc.publisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/ophtha-
dc.relation.ispartofOphthalmologyen_HK
dc.subject.meshDexamethasone - administration and dosage - adverse effects-
dc.subject.meshDrug Implants-
dc.subject.meshGlucocorticoids - administration and dosage - adverse effects-
dc.subject.meshMacular Edema - drug therapy - etiology - physiopathology-
dc.subject.meshRetinal Vein Occlusion - complications - physiopathology-
dc.titleRandomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusionen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0161-6420&volume=117&issue=6&spage=1134&epage=1146.e3&date=2010&atitle=Randomized,+sham-controlled+trial+of+dexamethasone+intravitreal+implant+in+patients+with+macular+edema+due+to+retinal+vein+occlusionen_HK
dc.identifier.emailLai, W: wicolai@hku.hken_HK
dc.identifier.authorityLai, WWK=rp00531en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.ophtha.2010.03.032-
dc.identifier.pmid20417567-
dc.identifier.scopuseid_2-s2.0-77952882990-
dc.identifier.hkuros181487en_HK
dc.identifier.hkuros192859-
dc.identifier.volume117en_HK
dc.identifier.issue6en_HK
dc.identifier.spage1134en_HK
dc.identifier.epage1146.e3en_HK
dc.identifier.isiWOS:000278224400008-
dc.identifier.citeulike7109878-

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