Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study

Ophthalmology

Volumn 122, Issue 9, 2015, Pages 1811-1819

  Pearce, Ian ^a   Banerjee, Sanjiv ^b   Burton, Ben J L ^c   Chakravarthy, Usha ^d   Downey, Louise ^e   Gale, Richard P ^f   Gibson, Jonathan ^g   Pagliarini, Sergio ^h   Patel, Jignesh ⁱ   Sivaprasad, Sobha ^j   Andrews, Chris ^k   Brittain, Christopher ^l   Warburton, James ^k  

^a ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^b UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^c JAMES PAGET UNIVERSITY HOSPITAL   (United Kingdom)

^d ROYAL VICTORIA HOSPITAL   (United Kingdom)

^e HULL AND EAST YORKSHIRE HOSPITALS NHS TRUST   (United Kingdom)

^f York Teaching Hospital   (United Kingdom)

^g BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

^h University Hospitals Coventry and Warwickshire NHS Trust   (United Kingdom)

ⁱ ESSEX COUNTY HOSPITAL   (United Kingdom)

^j KING S COLLEGE HOSPITAL   (United Kingdom)

^k Novartis Pharmaceuticals UK Ltd   (United Kingdom)

^l F HOFFMANN LA ROCHE LTD   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RANIBIZUMAB; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

ABNORMAL SENSATION; ADULT; ARTICLE; BEST CORRECTED VISUAL ACUITY; BLURRED VISION; CATARACT; CENTRAL RETINAL THICKNESS; CONJUNCTIVAL HEMORRHAGE; COUGHING; DIABETIC MACULAR EDEMA; DRUG EFFICACY; DRUG ERUPTION; DRUG SCREENING; DRY EYE; ENDOPHTHALMITIS; FEMALE; FOREIGN BODY SENSATION; HUMAN; HYPOGLYCEMIA; INCIDENCE; LASER SAFETY; LOADING DRUG DOSE; LOW LEVEL LASER THERAPY; LOWER RESPIRATORY TRACT INFECTION; MACULAR EDEMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; OPTICAL COHERENCE TOMOGRAPHY; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RHINOPHARYNGITIS; RISK ASSESSMENT; SIDE EFFECT; SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY; TRANSIENT ISCHEMIC ATTACK; UNITED KINGDOM; URINARY TRACT INFECTION; VISUAL ACUITY; VISUAL IMPAIRMENT; VITREOUS HEMORRHAGE; AGED; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC RETINOPATHY; DRUG EFFECTS; DRUG MONITORING; INTRAVITREAL DRUG ADMINISTRATION; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; RETREATMENT;

AGED; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; DIABETIC RETINOPATHY; DRUG MONITORING; FEMALE; HUMANS; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RETREATMENT; TOMOGRAPHY, OPTICAL COHERENCE; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISUAL ACUITY;

EID: 84939179104     PISSN: 01616420     EISSN: 15494713     Source Type: Journal    
DOI: 10.1016/j.ophtha.2015.05.038     Document Type: Article

References (19)

1. T.A. Ciulla, A.G. Amador, and B. Zinman Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies Diabetes Care 26 2003 2653 2664
2. P. Romero-Aroca Current status in diabetic macular edema treatments World J Diabetes 4 2013 165 169
3. D.S. Boyer, J.J. Hopkins, J. Sorof, and J.S. Ehrlich Anti-vascular endothelial growth factor therapy for diabetic macular edema Ther Adv Endocrinol Metab 4 2013 151 169
4. P. Massin, F. Bandello, J.G. Garweg, and et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE study): a 12-month, randomized, controlled, double-masked, multicenter phase II study Diabetes Care 33 2010 2399 2405
5. P. Mitchell, F. Bandello, U. Schmidt-Erfurth, et al. RESTORE Study Group The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema Ophthalmology 118 2011 615 625
6. Diabetic Retinopathy Clinical Research Network, M.J. Elman, N.M. Bressler, H. Qin, and et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema Ophthalmology 118 2011 609 614
7. P. Mitchell, T.Y. Wong, and Diabetic Macular Edema Treatment Guideline Working Group Management Paradigms for Diabetic Macular Edema Am J Ophthalmol 157 2014 505 513
8. European Medicines Agency. Summary of Product Characteristics. Lucentis 10 mg/ml solution for injection. Novartis. 2013. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/human/000715/WC500043546.pdf. Accessed December 6, 2013.
9. N. Ferrara, L. Damico, N. Shams, and et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration Retina 26 2006 859 870
10. D.M. Brown, Q.D. Nguyen, D.M. Marcus, and et al. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials RISE and RIDE Ophthalmology 120 2013 2013 2022
11. U. Schmidt-Erfurth, G.E. Lang, F.G. Holz, et al. The RESTORE Extension Study Group Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study Ophthalmology 121 2014 1045 1053
12. Diabetic Retinopathy Clinical Research Network, M.J. Elman, L.P. Aiello, R.W. Beck, and et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema Ophthalmology 117 2010 1064 1077
13. Q.D. Nguyen, S.M. Shah, A.A. Khwaja, and et al. Two-year outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. Ophthalmology 117 2010 2146 2151
14. Early Treatment Diabetic Retinopathy Study Group Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic retinopathy Study Report Number 2 Ophthalmology 94 1987 761 774
15. World Health Organization International Classification of Functioning, Disability and Health (ICF) 2001 World Health Organization Geneva, Switzerland
16. S.M. Hariprasad, D. Callanan, S. Gainey, and et al. Cystoid and diabetic macular edema treated with nepafenac 0.1% J Ocul Pharmacol Ther 23 2007 585 589
17. L.S. Matza, M.D. Rousculp, K. Malley, and et al. The longitudinal link between visual acuity and health-related quality of life in patients with diabetic retinopathy Health Qual Life Outcomes 6 2008 95
18. Prünte C. Efficacy and safety of ranibizumab in two treat and extend (T&E) versus pro re nata (PRN) treatment regimens in patients with visual impairment due to diabetic macular edema: 24-month results of RETAIN study. Presented as an oral presentation at The Association for Research and Vision in Ophthalmology, May 4-8, 2014, Orlando, Florida.
19. A.D. Fu, S.S. Yang, and H.R. McDonald The clinical management of diabetic retinopathy Adv Stud Ophthalmol 2004 18 29