Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

被引:560
作者
Haller, Julia A. [1 ]
Bandello, Francesco [2 ]
Belfort, Rubens, Jr. [3 ]
Blumenkranz, Mark S. [4 ]
Gillies, Mark [5 ]
Heier, Jeffrey [6 ]
Loewenstein, Anat [7 ]
Yoon, Young Hee [8 ]
Jiao, Jenny [9 ]
Li, Xiao-Yan [9 ]
Whitcup, Scott M. [9 ]
机构
[1] Wills Eye Inst, Philadelphia, PA 19107 USA
[2] Univ Vita Salute, Hosp San Raffaele, Milan, Italy
[3] Univ Fed Sao Paulo, Vis Inst, Sao Paulo, Brazil
[4] Stanford Univ, Stanford, CA 94305 USA
[5] Univ Sydney, Sydney, NSW 2006, Australia
[6] Ophthalm Consultants Boston, Boston, MA USA
[7] Tel Aviv Med Ctr & Sch Med, Tel Aviv, Israel
[8] Asan Med Ctr, Seoul, South Korea
[9] Allergan Pharmaceut Inc, Irvine, CA USA
关键词
STANDARD-CARE; TRIAMCINOLONE; SECONDARY; EFFICACY; SAFETY;
D O I
10.1016/j.ophtha.2011.05.014
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Objective: To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Design: Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. Participants: We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. Methods: At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250 mu m. Main Outcome Measures: The primary outcome for the open-label extension was safety; BCVA was also evaluated. Results: At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a >= 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A >= 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Conclusions: Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2011; 118: 2453-2460 (C) 2011 by the American Academy of Ophthalmology.
引用
收藏
页码:2453 / 2460
页数:8
相关论文
共 8 条
[1]  
Boyer D, 2010, OPHTHALMOLOGY, V117, P1860, DOI 10.1016/j.ophtha.2010.02.022
[2]   Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion Six-Month Primary End Point Results of a Phase III Study [J].
Campochiaro, Peter A. ;
Heier, Jeffrey S. ;
Feiner, Leonard ;
Gray, Sarah ;
Saroj, Namrata ;
Rundle, Amy Chen ;
Murahashi, Wendy Yee ;
Rubio, Roman G. .
OPHTHALMOLOGY, 2010, 117 (06) :1102-U111
[3]   Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion [J].
Haller, Julia A. ;
Bandello, Francesco ;
Belfort, Rubens, Jr. ;
Blumenkranz, Mark S. ;
Gillies, Mark ;
Heier, Jeffrey ;
Loewenstein, Anat ;
Yoon, Young-Hee ;
Jacques, Marie-Louise ;
Jiao, Jenny ;
Li, Xiao-Yan ;
Whitcup, Scott M. .
OPHTHALMOLOGY, 2010, 117 (06) :1134-U164
[4]  
Ip MS, 2009, ARCH OPHTHALMOL-CHIC, V127, P1101, DOI 10.1001/archophthalmol.2009.234
[5]   Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema [J].
Kuppermann, Baruch D. ;
Blumenkranz, Mark S. ;
Haller, Julia A. ;
Williams, George A. ;
Weinberg, David V. ;
Chou, Connie ;
Whitcup, Scott M. .
ARCHIVES OF OPHTHALMOLOGY, 2007, 125 (03) :309-317
[6]   PHOTOCOAGULATION FOR DIABETIC MACULAR EDEMA - EARLY TREATMENT DIABETIC-RETINOPATHY STUDY REPORT 1. EARLY TREATMENT DIABETIC RETINOPATHY STUDY RESEARCH GROUP [J].
PATZ, A ;
RICE, TA ;
MURPHY, RP ;
NEWSOME, DA ;
SHERMAN, SH ;
FINE, SL ;
AIELLO, LM ;
RAND, LI ;
BRIONES, JC ;
SHAH, ST ;
MYERS, FL ;
BRESNICK, GH ;
DAVIS, MD ;
CHANDRA, SR ;
WALLOW, IHL ;
STEVENS, TS ;
KLEIN, R ;
FLYNN, HW ;
BLANKENSHIP, GW ;
KNOBLOCH, WH ;
RAMSAY, RC ;
CANTRILL, HL ;
HODGKINSON, BJ ;
RYAN, SJ ;
LIANG, JC ;
THOMAS, EL ;
KLEIN, ML ;
HANDELMAN, IL ;
SIPPERLEY, JO ;
CHENOWETH, RG ;
ERNEST, JT ;
LIANG, JC ;
CUNHA-VAZ, J ;
GOLDBERG, MF ;
LINDBERG, CR ;
VYGANTAS, C ;
KLEIN, HJ ;
BLAIR, N ;
REDNAM, K ;
KOPELOW, SM ;
SHABO, AL ;
STRAATSMA, BR ;
BRIONES, JC ;
KASSOFF, A ;
LITTLE, HL ;
JACK, RL ;
CAVENDER, JC ;
AI, E ;
SORENSON, RL ;
TASMAN, WS .
ARCHIVES OF OPHTHALMOLOGY, 1985, 103 (12) :1796-1806
[7]   Branch retinal vein occlusion: Pathogenesis, visual prognosis, and treatment modalities [J].
Rehak, Jiri ;
Rehak, Matus .
CURRENT EYE RESEARCH, 2008, 33 (02) :111-131
[8]  
Scott IU, 2009, ARCH OPHTHALMOL-CHIC, V127, P1115, DOI 10.1001/archophthalmol.2009.233