Document Detail


Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study.
MedLine Citation:
PMID:  20855114     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).
DESIGN: Prospective, randomized, interventional, multicenter clinical trial.
PARTICIPANTS: One hundred twenty-six patients with DME.
METHODS: 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.
MAIN OUTCOME MEASURES: The mean change from baseline in best-corrected visual acuity (BCVA) at month 24.
RESULTS: 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.
CONCLUSIONS: 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.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Authors:
Quan Dong Nguyen; Syed Mahmood Shah; Afsheen A Khwaja; Roomasa Channa; Elham Hatef; Diana V Do; David Boyer; Jeffery S Heier; Prema Abraham; Allen B Thach; Eugene S Lit; Bradley S Foster; Erik Kruger; Pravin Dugel; Thomas Chang; Arup Das; Thomas A Ciulla; John S Pollack; Jennifer I Lim; Dean Eliott; Dean Eliot; Peter A Campochiaro;
Related Documents :
18254344 - Profound choroidal hypoperfusion after combined photodynamic therapy and intravitreal t...
20491044 - Experience with intravitreal bevacizumab as a preoperative adjunct in 23-g vitrectomy f...
23518374 - The world post stich: is this a "game changer?" a surgeon's perspective - revasculariza...
2243674 - Prophylaxis of aphakic cystoid macular edema without corticosteroids. a paired-comparis...
10750134 - Defibrillators in nonischemic cardiomyopathy treatment evaluation.
21454084 - Comparison of mandibular vertical growth in hemifacial microsomia patients treated with...
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-09-19
Journal Detail:
Title:  Ophthalmology     Volume:  117     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-25     Completed Date:  2010-11-03     Revised Date:  2011-08-04    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2146-51     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Antibodies, Monoclonal / administration & dosage*
Combined Modality Therapy
Diabetic Retinopathy / drug therapy*
Fluorescein Angiography
Humans
Injections
Laser Coagulation
Macular Edema / drug therapy*
Prospective Studies
Retreatment
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Visual Acuity / physiology
Vitreous Body
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/ranibizumab
Comments/Corrections
Erratum In:
Ophthalmology. 2011 Jun;118(6):1016
Note: Eliot, Dean [corrected to Eliott, Dean]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Role of Rho-ROCK signaling in MOLT4 cells metastasis induced by CCL25.
Next Document:  In the company of my sisters: sister circles as an anxiety intervention for professional African Ame...