Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study

To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Prospective, randomized, interventional, multicenter clinical trial. One hundred twenty-six patients with DME. Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and...

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Vydáno v:	Ophthalmology (Rochester, Minn.) Ročník 117; číslo 11; s. 2146
Hlavní autoři:	Nguyen, Quan Dong, Shah, Syed Mahmood, Khwaja, Afsheen A, Channa, Roomasa, Hatef, Elham, Do, Diana V, Boyer, David, Heier, Jeffery S, Abraham, Prema, Thach, Allen B, Lit, Eugene S, Foster, Bradley S, Kruger, Erik, Dugel, Pravin, Chang, Thomas, Das, Arup, Ciulla, Thomas A, Pollack, John S, Lim, Jennifer I, Eliott, Dean, Eliot, Dean, Campochiaro, Peter A
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 01.11.2010
Témata:	Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Combined Modality Therapy Diabetic Retinopathy - drug therapy Fluorescein Angiography Humans Injections Laser Coagulation Macular Edema - drug therapy Prospective Studies Ranibizumab Retreatment Time Factors Tomography, Optical Coherence Treatment Outcome Visual Acuity - physiology Vitreous Body
ISSN:	1549-4713, 1549-4713
On-line přístup:	Zjistit podrobnosti o přístupu
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Abstract	To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Prospective, randomized, interventional, multicenter clinical trial. One hundred twenty-six patients with DME. Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Proprietary or commercial disclosure may be found after the references.
AbstractList	To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).OBJECTIVESTo determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).Prospective, randomized, interventional, multicenter clinical trial.DESIGNProspective, randomized, interventional, multicenter clinical trial.One hundred twenty-six patients with DME.PARTICIPANTSOne hundred twenty-six patients with DME.Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ.METHODSSubjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ.The mean change from baseline in best-corrected visual acuity (BCVA) at month 24.MAIN OUTCOME MEASURESThe mean change from baseline in best-corrected visual acuity (BCVA) at month 24.After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively.RESULTSAfter the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively.Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema.CONCLUSIONSIntraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema.Proprietary or commercial disclosure may be found after the references.FINANCIAL DISCLOSURE(S)Proprietary or commercial disclosure may be found after the references. To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Prospective, randomized, interventional, multicenter clinical trial. One hundred twenty-six patients with DME. Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Proprietary or commercial disclosure may be found after the references.
Author	Dugel, Pravin Channa, Roomasa Lit, Eugene S Thach, Allen B Boyer, David Foster, Bradley S Nguyen, Quan Dong Heier, Jeffery S Ciulla, Thomas A Eliott, Dean Shah, Syed Mahmood Hatef, Elham Lim, Jennifer I Khwaja, Afsheen A Abraham, Prema Das, Arup Eliot, Dean Pollack, John S Do, Diana V Chang, Thomas Kruger, Erik Campochiaro, Peter A
Author_xml	– sequence: 1 givenname: Quan Dong surname: Nguyen fullname: Nguyen, Quan Dong organization: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA – sequence: 2 givenname: Syed Mahmood surname: Shah fullname: Shah, Syed Mahmood – sequence: 3 givenname: Afsheen A surname: Khwaja fullname: Khwaja, Afsheen A – sequence: 4 givenname: Roomasa surname: Channa fullname: Channa, Roomasa – sequence: 5 givenname: Elham surname: Hatef fullname: Hatef, Elham – sequence: 6 givenname: Diana V surname: Do fullname: Do, Diana V – sequence: 7 givenname: David surname: Boyer fullname: Boyer, David – sequence: 8 givenname: Jeffery S surname: Heier fullname: Heier, Jeffery S – sequence: 9 givenname: Prema surname: Abraham fullname: Abraham, Prema – sequence: 10 givenname: Allen B surname: Thach fullname: Thach, Allen B – sequence: 11 givenname: Eugene S surname: Lit fullname: Lit, Eugene S – sequence: 12 givenname: Bradley S surname: Foster fullname: Foster, Bradley S – sequence: 13 givenname: Erik surname: Kruger fullname: Kruger, Erik – sequence: 14 givenname: Pravin surname: Dugel fullname: Dugel, Pravin – sequence: 15 givenname: Thomas surname: Chang fullname: Chang, Thomas – sequence: 16 givenname: Arup surname: Das fullname: Das, Arup – sequence: 17 givenname: Thomas A surname: Ciulla fullname: Ciulla, Thomas A – sequence: 18 givenname: John S surname: Pollack fullname: Pollack, John S – sequence: 19 givenname: Jennifer I surname: Lim fullname: Lim, Jennifer I – sequence: 20 givenname: Dean surname: Eliott fullname: Eliott, Dean – sequence: 21 givenname: Dean surname: Eliot fullname: Eliot, Dean – sequence: 22 givenname: Peter A surname: Campochiaro fullname: Campochiaro, Peter A
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/20855114$$D View this record in MEDLINE/PubMed
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Copyright	Copyright © 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Snippet	To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Prospective, randomized, interventional, multicenter... To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).OBJECTIVESTo determine the long-term effects of...
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SubjectTerms	Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Combined Modality Therapy Diabetic Retinopathy - drug therapy Fluorescein Angiography Humans Injections Laser Coagulation Macular Edema - drug therapy Prospective Studies Ranibizumab Retreatment Time Factors Tomography, Optical Coherence Treatment Outcome Visual Acuity - physiology Vitreous Body
Title	Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study
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