Clinical trial NCT01552408 - References

Diabetic Macular Edema — Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE)

Citation(s)

•   Aiello LP, Edwards AR, Beck RW, Bressler NM, Davis MD, Ferris F, Glassman AR, Ip MS, Miller KM; Diabetic Retinopathy Clinical Research Network
  Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2010 May;117(5):946-53. doi: 10.1016/j.ophtha.2009.10.002. Epub 2010 Feb 1.
•   Audren F, Tod M, Massin P, Benosman R, Haouchine B, Erginay A, Caulin C, Gaudric A, Bergmann JF
  Pharmacokinetic-pharmacodynamic modeling of the effect of triamcinolone acetonide on central macular thickness in patients with diabetic macular edema. Invest Ophthalmol Vis Sci. 2004 Oct;45(10):3435-41.
•   Cruickshanks KJ, Moss SE, Klein R, Klein BE
  Physical activity and the risk of progression of retinopathy or the development of proliferative retinopathy. Ophthalmology. 1995 Aug;102(8):1177-82.
•   Diabetic Retinopathy Clinical Research Network (DRCR
  net), Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.
•   Diabetic Retinopathy Clinical Research Network, Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR
  A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology. 2007 Oct;114(10):1860-7. Epub 2007 Aug 15.
•   Four risk factors for severe visual loss in diabetic retinopathy
  The third report from the Diabetic Retinopathy Study. The Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1979 Apr;97(4):654-5.
•   From the NIH: Study identifies four factors in diabetic retinopathy associated with high risk of severe visual loss
  JAMA. 1979 Apr 13;241(15):1581.
•   Jonas JB, Strueven V, Kamppeter BA, Harder B, Spandau UH, Schlichtenbrede F
  Visual acuity change after intravitreal triamcinolone in various types of exudative age-related macular degeneration. J Ocul Pharmacol Ther. 2006 Oct;22(5):370-6.
•   Klein M
  Prevention and treatment of the complications of diabetes mellitus. N Engl J Med. 1995 Sep 21;333(12):802.
•   Klein R, Meuer SM, Moss SE, Klein BE
  Retinal microaneurysm counts and 10-year progression of diabetic retinopathy. Arch Ophthalmol. 1995 Nov;113(11):1386-91.
•   Lüddeke HJ
  [Continuing education provided by the Diabetes Society. Results of the UKPDS (United Kingdom Diabetes Society) and therapeutic guidelines concerning diabetes type II]. Fortschr Med. 1998 Nov 30;116(33):35-8. German.
•   Martidis A, Duker JS, Greenberg PB, Rogers AH, Puliafito CA, Reichel E, Baumal C
  Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002 May;109(5):920-7.
•   Muggeo M
  DCCT and us: how far are we from implementation? Acta Diabetol. 1993;30(3):115-7.
•   Photocoagulation for diabetic macular edema
  Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
•   Scott IU, Danis RP, Bressler SB, Bressler NM, Browning DJ, Qin H; Diabetic Retinopathy Clinical Research Network
  Effect of focal/grid photocoagulation on visual acuity and retinal thickening in eyes with non-center-involved diabetic macular edema. Retina. 2009 May;29(5):613-7. doi: 10.1097/IAE.0b013e3181a2c07a.
•   Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema
  Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74.
•   Watkins P
  The UKPDS. A model for gathering the evidence for the management of chronic diseases. UK Prospective Diabetes Study Group. J R Coll Physicians Lond. 1998 Nov-Dec;32(6):510-1.
•   Writing Committee for the Diabetic Retinopathy Clinical Research Network, Fong DS, Strauber SF, Aiello LP, Beck RW, Callanan DG, Danis RP, Davis MD, Feman SS, Ferris F, Friedman SM, Garcia CA, Glassman AR, Han DP, Le D, Kollman C, Lauer AK, Recchia FM, Solomon SD
  Comparison of the modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Arch Ophthalmol. 2007 Apr;125(4):469-80.

A Phase I/II, Randomized, Study for Diabetic Macular Edema Using 0.3mg Ranibizumab Combined With Targeted PRP Monthly for 4 Months,Then PRN vs. 0.3mg Ranibizumab 4 Months Monotherapy, Then as Needed(DME-AntiVEgf) DAVE

Details for clinical trial NCT01552408