Abstract:
Importance:The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear. Objective:To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months. Design, Setting, and Participants:This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography. Interventions:Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions. Main Outcomes and Measures:Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions. Results:Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001). Participants in the combination group received fewer ranibizumab injections (median, 6.0 [interquartile range (IQR), 4.0-11.0]) than the monotherapy group (median, 12.0 [IQR, 7.0-17.0]) up to month 24. The combination group required a median of 2.0 (IQR, 1.0-3.0) vPDT treatments for 24 months, with 75 of 168 participants (44.6%) requiring only 1 vPDT treatment. Conclusions and Relevance:The 24-month data findings confirm that ranibizumab therapy, given as monotherapy or in combination with vPDT, is efficacious and safe for treatment of PCV. Combination therapy with vPDT added to ranibizumab achieved superior BCVA gain, increased odds of complete polypoidal lesion regression, and fewer treatment episodes compared with ranibizumab monotherapy. Trial Registration:ClinicalTrials.gov Identifier: NCT01846273.
journal_name
JAMA Ophthalmoljournal_title
JAMA ophthalmologyauthors
Lim TH,Lai TYY,Takahashi K,Wong TY,Chen LJ,Ruamviboonsuk P,Tan CS,Lee WK,Cheung CMG,Ngah NF,Patalauskaite R,Margaron P,Koh A,EVEREST II Study Group.doi
10.1001/jamaophthalmol.2020.2443subject
Has Abstractpub_date
2020-09-01 00:00:00pages
935-942issue
9eissn
2168-6165issn
2168-6173pii
2768203journal_volume
138pub_type
杂志文章abstract:Importance:The ocular surface is continuously exposed to the environment. Although studies have focused on associations between outdoor environmental conditions and dry eye, information on associations between the indoor environment and dry eye is lacking. Objective:To determine associations between the indoor environ...
journal_title:JAMA ophthalmology
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journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:JAMA ophthalmology
pub_type: 杂志文章
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journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究
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pub_type: 杂志文章,meta分析,评审
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abstract:Importance:There are limited published data on the phenotype of retinitis pigmentosa (RP) related to CNGB1 variants. These data are needed both for prognostic counseling of patients and for understanding potential treatment windows. Objective:To describe the detailed clinical and molecular genetic findings in a series...
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更新日期:2016-04-01 00:00:00
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更新日期:2013-03-01 00:00:00
abstract:Importance:Knowledge of the incidence and progression of diabetic retinopathy (DR) after gastric bypass surgery (GBP) in patients with obesity and diabetes could guide the management of these patients. Objective:To investigate the incidence of diabetic ocular complications in patients with type 2 diabetes after GBP co...
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abstract:IMPORTANCE:This study confirmed the long-term outcomes of the ZB5M phakic intraocular lens (PIOL). OBJECTIVE:To evaluate the potential long-term risk associated with ZB5M PIOL implantation. DESIGN, SETTING, AND PARTICIPANTS:A retrospective, nonrandomized, consecutive cohort study of a total of 208 eyes implanted with...
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更新日期:2013-12-01 00:00:00
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journal_title:JAMA ophthalmology
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更新日期:2018-02-01 00:00:00
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更新日期:2020-12-17 00:00:00
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更新日期:2016-08-01 00:00:00
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更新日期:2019-05-01 00:00:00
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更新日期:2014-02-01 00:00:00
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更新日期:2014-06-01 00:00:00
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更新日期:2019-01-01 00:00:00
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更新日期:2013-01-01 00:00:00
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pub_type: 杂志文章,随机对照试验
doi:10.1001/jamaophthalmol.2014.1019
更新日期:2014-08-01 00:00:00