Pooled efficacy results from two multinational randomized controlled clinical trials of a single intravitreous injection of highly purified ovine hyaluronidase (Vitrase®) for the management of vitreous hemorrhage

American Journal of Ophthalmology

Volumn 140, Issue 4, 2005, Pages 573-584

  Kuppermann, Baruch D ^a   Thomas, Edgar L ^b   De Smet, Marc D ^c   Grillone, Lisa R ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b RETINA VITREOUS ASSOCIATES MEDICAL GROUP   (United States)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d ISTA Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYALURONIDASE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; VISUAL ACUITY; VITREOUS HEMORRHAGE;

DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYALURONOGLUCOSAMINIDASE; INJECTIONS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME; VISUAL ACUITY; VITREOUS BODY; VITREOUS HEMORRHAGE;

EID: 26844520874     PISSN: 00029394     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajo.2005.04.018     Document Type: Article

References (24)

1. G. Lindgren, L. Sjodell, B. Lindblom A prospective study of dense spontaneous vitreous hemorrhage Am J Ophthalmol 119 1995 458 465
2. R. Klein, B.E. Klein, S.E. Moss, M.D. Davis, D.L. DeMets The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years Arch Ophthalmol 102 1984 520 526
3. R. Klein, B.E. Klein, S.E. Moss, M.D. Davis, D.L. DeMets The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years Arch Ophthalmol 102 1984 527 532
4. S. Sharma, H. Hollands, G.C. Brown, M.M. Brown, G.K. Shah, S.M. Sharma The cost-effectiveness of early vitrectomy for the treatment of vitreous hemorrhage in diabetic retinopathy Curr Opin Ophthalmol 12 2001 230 234
5. R. Sarrafizadeh, T.S. Hassan, A.J. Ruby Incidence of retinal detachment and visual outcome in eyes presenting with posterior vitreous separation and dense fundus-obscuring vitreous hemorrhage Ophthalmology 108 2001 2273 2278
6. D.R. Globe, J. Wu, S.P. Azen, R. Varma The impact of visual impairment on self-reported visual functioning in Latinos the Los Angeles Latino Eye Study Ophthalmology 111 2004 1141 1149
7. M.M. Brown, G.C. Brown, S. Sharma, B. Busbee Quality of life associated with visual loss a time tradeoff utility analysis comparison with medical health states Ophthalmology 110 2003 1076 1081
8. A.L. Coleman, K. Stone, S.K. Ewing Higher risk of multiple falls among elderly women who lose visual acuity Ophthalmology 111 2004 857 862
9. C.W. Spraul, H.E. Grossniklaus Vitreous hemorrhage Surv Ophthalmol 42 1997 3 39
10. D.E. Eifrig, D.L. Lockhart, R.D. Berglund, W.H. Knobloch Pars plana vitrectomy Ophthalmic Surg 9 1978 76 88
11. A. Amirikia, I.U. Scott, T.G. Murray, H.W. Flynn Jr, W.E. Smiddy, W.J. Feuer Outcomes of vitreoretinal surgery for complications of branch retinal vein occlusion Ophthalmology 108 2001 372 376
12. B.D. Brent, M. Gonce, J.G. Diamond Pars plana vitrectomy for complications of retinal arterial macroaneurysms - a case series Ophthalmic Surg 24 1993 534 536
13. I.U. Scott Vitreoretinal surgery for complications of branch retinal vein occlusion Curr Opin Ophthalmol 13 2002 161 166
14. J.A. Met, A.L. Maberley, S.C. Richards Pars plana vitrectomy for macular degenerative disorders Can J Ophthalmol 26 1991 374 376
15. W.E. Smiddy, R.D. Isernhagen, R.G. Michels, B.M. Glaser, S.N. de Bustros Vitrectomy for nondiabetic vitreous hemorrhage. Retinal and choroidal vascular disorders Retina 8 1988 88 95
16. C. Azzolini, U. Menchini, A. Pece, F. Camesasca, V. Giuliani Age-related macular degeneration and vitreous hemorrhage Eur J Ophthalmol 1 1991 142 147
17. J. Biswas, T. Sharma, L. Gopal, H.N. Madhavan, K.N. Sulochana, S. Ramakrishnan Eales disease - an update Surv Ophthalmol 47 2002 197 214
18. R. Varma, M. Ying-Lai, R. Klein, S.P. Azen Prevalence and risk indicators of visual impairment and blindness in Latinos the Los Angeles Latino Eye Study Ophthalmology 111 2004 1132 1140
19. R.B. Bhisitkul Anticipation for enzymatic vitreolysis Br J Ophthalmol 85 2001 1 2
20. J. Ludowieg, B. Vennesland, A. Dorfman The mechanism of action of hyaluronidase J Biol Chem 236 1961 333 339
21. J.T. Holladay Proper method for calculating average visual acuity J Refract Surg 13 1997 388 391
22. J.L. Fleiss, B. Levin, C.H. Paik Statistical methods for rates and proportions 2nd ed. 1981 John Wiley and Sons New York 27 29
23. K.K.G. Lan, D.L. DeMets Discrete sequential boundaries for clinical trials Biometrika 70 1983 659 663
24. P.C. O'Brien, T.R. Fleming A multiple testing procedure for clinical trials Biometrics 35 1979 549 556