Sponsor study identifier
interventional
48
1 country
8
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 18, 2015
Actual (reported)March 26, 2015
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
after 12 months
The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity
after 12 months
The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)
after 12 months
Intravitreal dexamethasone 0.7mg implant (Ozurdex)
Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 660-702, South Korea
Kosin University Gospel Hospital
Busan, 602-702, South Korea
Dong-A University hospital
Busan, 602-715, South Korea
Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.
Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995 Jan;102(1):7-16. doi: 10.1016/s0161-6420(95)31052-4.
Hyun Woong Kim, M.D.
Inje University
Ji Eun Lee, M.D.
Pusan National University Hospital
Joo Eun Lee, M.D.
Inje University Haeundae Paik Hospital
Woo Jin Jeung, M.D.
Dong-A University Hospital
First Submitted
March 18, 2015
First Posted
March 26, 2015
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab
The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography
after 12 months
The average change in number of microaneurysm in macula
after 12 months
The progression rate of cataract
for 12 months
Contact the study team to confirm eligibility.
Pusan national university hospital
Busan, 602-739, South Korea
Inje University Haeundae Paik hospital
Busan, 612-030, South Korea
Inje University Busan Paik hospital
Busan, 614-735, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Yeungnam University Medical Center
Daegu, 705-717, South Korea
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
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.
Haller JA, Kuppermann BD, Blumenkranz MS, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010 Mar;128(3):289-96. doi: 10.1001/archophthalmol.2010.21.
Yoon CK, Sagong M, Shin JP, Lee SJ, Lee JE, Lee JE, Chung I, Jeong WJ, Pak KY, Kim HW. Title: efficacy of intravitreal dexamethasone implant on hard exudate in diabetic macular edema. BMC Ophthalmol. 2021 Jan 15;21(1):41. doi: 10.1186/s12886-020-01786-2.
Sang Joon Lee, M.D.
Kosin University Gospel Hospital
In Young Chung, M.D.
Gyeongsang National University Hospital
Jae Pil Shin, M.D.
Kyungpook National University Hospital
Woo Hyok Chang, M.D.
Yeungnam University Hospital
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 6, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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