Predicting response of vitreous hemorrhage after intravitreous injection of highly purified ovine hyaluronidase (vitrase) in patients with diabetes

Investigative Ophthalmology and Visual Science

Volumn 49, Issue 10, 2008, Pages 4219-4225

  Bhavsar, Abdhish R ^a,b   Grillone, Lisa R ^b,d   McNamara, Timothy R ^b   Gow, James A ^b   Hochberg, Alan M ^c   Pearson, Ronald K ^c  

^a Retina Center   (United States)

^b ISTA Pharmaceuticals Inc   (United States)

^c ProSanos Corporation   (United States)

^d PharmaQuest Associates LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYALURONIDASE; HYALURONOGLUCOSAMINIDASE; PRESERVATIVE;

AREA UNDER THE CURVE; ARTICLE; DIABETES MELLITUS; EYE EXAMINATION; EYE FUNDUS; HUMAN; LOW LEVEL LASER THERAPY; MAJOR CLINICAL STUDY; POST HOC ANALYSIS; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RETROSPECTIVE STUDY; SINGLE DRUG DOSE; VITREOUS BODY; VITREOUS HEMORRHAGE; ANIMAL; BIOLOGICAL MODEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; INJECTION; MULTICENTER STUDY; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; ROC CURVE; SENSITIVITY AND SPECIFICITY; SHEEP; TREATMENT OUTCOME;

ANIMALS; AREA UNDER CURVE; DIABETES COMPLICATIONS; DOUBLE-BLIND METHOD; HUMANS; HYALURONOGLUCOSAMINIDASE; INJECTIONS; MODELS, BIOLOGICAL; PRESERVATIVES, PHARMACEUTICAL; REPRODUCIBILITY OF RESULTS; ROC CURVE; SENSITIVITY AND SPECIFICITY; SHEEP; TREATMENT OUTCOME; VITREOUS BODY; VITREOUS HEMORRHAGE;

EID: 53449091428     PISSN: 01460404     EISSN: 15525783     Source Type: Journal    
DOI: 10.1167/iovs.07-1602     Document Type: Article

References (27)

1. Frank RN. Diabetic Retinopathy. N Engl J Med. 2004;350:48-58.
2. Spraul CW, Grossniklaus HE. Vitreous Hemorrhage. Surv Ophthalmol. 1997;42:3-39.
3. Lindgren G, Sjodell L, Lindblom B. A prospective study of dense spontaneous vitreous hemorrhage. Am J Ophthalmol. 1995;119:458-465.
4. Vitale S, Cotch MF, Sperduto RD. Prevalence of visual impairment in the United States. JAMA. 2006;295:2158-2163.
5. The Diabetic Retinopathy Study Research Group: Preliminary report on the effect of photocoagulation therapy. Am J Ophthalmol. 1976;81:383-396.
6. Coleman AL, Stone K, Ewing SK, et al. Higher risk of multiple falls among elderly women who lose visual acuity. Ophthalmology. 2004;111:857-862. (Pubitemid 38586675)
7. Pardo-Munoz A, Muriel-Herrero A, Abraira V, et al. Phacoemulsification in previously vitrectomized patients: an analysis of the surgical results in 100 eyes as well as the factors contributing to the cataract formation. Eur J Ophthalmol. 2006;16:52-59.
8. Bhisitkul RB. Anticipation for enzymatic vitreolysis. Br J Ophthalmol. 2001;85:1-2.
9. Vitrase (Hyaluronidase for Injection) Lyophilized, Ovine [package insert]. Irvine, CA: ISTA Pharmaceuticals, Inc.; 2004.
10. Kuppermann BD, Thomas EL, de Smet MD, et al. 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. Am J Ophthalmol. 2005;140:573-584. (Pubitemid 41455296)
11. Kuppermann BD, Thomas EL, de Smet MD, et al. Safety results of two phase III trials of an intravitreous injection of highly purified ovine hyaluronidase (Vitrase) for the management of vitreous hemorrhage. Am J Ophthalmol. 2005;140:585-598.
12. Duda RO, Hart PE, Stork DG. Pattern Classification. 2nd ed. New York: John Wiley & Sons; 2001:37.
13. Agresti A. Categorical Data Analysis. 2nd ed. Hoboken, NJ: John Wiley & Sons; 2002:228-230.
14. Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982;143:29-36.
15. Venables WN, Ripley BD. Modern Applied Statistics with S. 4th ed. New York: Springer-Verlag; 2002:126-132.
16. Thomas E, Grillone LR, McNamara TR, et al. Preliminary Evaluation of an Early Surrogate Marker for Successful Laser Treatment in Ovine Hyaluronidase-Treated Subjects with Diabetes and Severe Vitreous Hemorrhage. 2006 Food and Drug Administration Science Forum; April 18-20, 2006; Washington, DC. Abstract C-04.
17. Brown MM, Brown GC, Sharma S, et al. Quality of life associated with visual loss: a time tradeoff utility analysis comparison with medical health states. Ophthalmology. 2003;110:1076-1081. (Pubitemid 36676636)
18. Muthukumar T, Dadhania D, Ding R, et al. Messenger RNA for FOXP3 in the urine of renal-allograft recipients. N Engl J Med. 2005;353:2342-2351. (Pubitemid 41713746)
19. Mitchell SL, Kiely DK, Hamel MB, et al. Estimating prognosis for nursing home residents with advanced dementia. JAMA. 2004;291:2734-2740. (Pubitemid 38725423)
20. Walter LC, Brand RJ, Counsell SR, et al. Development and validation of a prognostic index for 1-year mortality in older adults after hospitalization. JAMA. 2001;285:2987-2994.
21. Newman TB, Liljestrand P, Escobar GJ. Combining clinical risk factors with serum bilirubin levels to predict hyperbilirubinemia in newborns. Arch Pediatr Adolesc Med. 2005;159:113-119. (Pubitemid 40194175)
22. Read JS, Rich KC, Korelitz JJ, et al. Quantification of human immunodeficiency virus type 1 p24 antigen and antibody rivals human immunodeficiency virus type 1 RNA and CD4+ enumeration for prognosis. Pediatr Infect Dis J. 2000;19:544-551.
23. Etzioni R, Falcon S, Gann PH, et al. Prostate-specific antigen and free prostate specific antigen in the early detection of prostate cancer: do combination tests improve detection? Cancer Epidemiol Biomark Prevent. 2004;13:1640-1645. (Pubitemid 39331886)
24. Budenz DL, Michael A, Chang RT, et al. Sensitivity and specificity of the StratusOCT for perimetric glaucoma. Ophthalmology. 2005;112:3-9. (Pubitemid 40075311)
25. Burnstein Y, Ellish NJ, Magbalon M, et al. Comparison of frequency doubling perimetry with Humphrey visual field analysis in a glaucoma practice. Am J Ophthalmol. 2000;129:328-333. (Pubitemid 30126078)
26. Cullinane AB, Waldock A, Diamond JP, et al. Optic disc cup slope and visual field indices in normal, ocular hypertensive and early glaucomatous eyes. Br J Ophthalmology. 2002;86:555-559. (Pubitemid 34454503)
27. Bhavsar AR, Pearson RK, Hochberg AM, et al. A Simple Predictor of Vitrase Efficacy for Successful Laser Treatment in Diabetic Patients with Severe Vitreous Hemorrhage. The American Society of Retinal Specialists 24th Annual Meeting, September 9-13, 2006, Cannes, France. Poster 309.