Reduktion i forekomsten af center-involveret diabetisk makulært ødem
25. august 2016 opdateret af: Chromaderm, Inc.
Formålet med denne undersøgelse er at afgøre, om ruboxistaurin kan hjælpe med at bremse forværringen af en øjensygdom kaldet makulært ødem hos patienter med diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
731
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Parramatta, New South Wales, Australien, 2150
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Sydney, New South Wales, Australien, 2000
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Westmead, New South Wales, Australien, 2145
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South Australia
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Woodville, South Australia, Australien, 5011
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Western Australia
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Nedlands, Western Australia, Australien, 6009
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Curitiba, Brasilien, 80420-170
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Goiania, Brasilien, 74210-010
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Sao Paulo, Brasilien, 05403-010
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E1
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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London, Ontario, Canada, N6A 4G5
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Ottawa, Ontario, Canada, K1H 1A2
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Aarhus, Danmark, 8000
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Glostrup, Danmark, 2600
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Moscow, Den Russiske Føderation, 117036
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Saint Petersburg, Den Russiske Føderation, 195176
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Bristol, Det Forenede Kongerige, BS1 2LX
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London, Det Forenede Kongerige, EC1V 2PD
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Merseyside
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Liverpool, Merseyside, Det Forenede Kongerige, L7 8XP
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Scotland
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Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
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West Midlands
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Birmingham, West Midlands, Det Forenede Kongerige, B9 5SS
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Artesia, California, Forenede Stater, 90701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Palm Springs, California, Forenede Stater, 92262
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poway, California, Forenede Stater, 92064
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Walnut Creek, California, Forenede Stater, 94598
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Colorado
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Denver, Colorado, Forenede Stater, 80262
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Connecticut
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New London, Connecticut, Forenede Stater, 06320
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Jacksonville, Florida, Forenede Stater, 32204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sunrise, Florida, Forenede Stater, 33351
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
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Augusta, Georgia, Forenede Stater, 30909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Wheaton, Illinois, Forenede Stater, 60187
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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Peabody, Massachusetts, Forenede Stater, 01960
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49525
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Independence, Missouri, Forenede Stater, 64055
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Teaneck, New Jersey, Forenede Stater, 07666
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Rockville Center, New York, Forenede Stater, 11570
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58104
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
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Cincinnati, Ohio, Forenede Stater, 45242
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Cleveland, Ohio, Forenede Stater, 44195
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
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Texas
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Arlington, Texas, Forenede Stater, 76012
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Dallas, Texas, Forenede Stater, 75231
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Houston, Texas, Forenede Stater, 77030
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Utah
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Ogden, Utah, Forenede Stater, 84403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salt Lake City, Utah, Forenede Stater, 84107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bordeaux, Frankrig, 33076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nantes, Frankrig, 44093
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris, Frankrig, 75010
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Amsterdam, Holland, 1081 HV
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Rotterdam, Holland, 3011 BH
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Chennai, Indien, 600006
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Hyderabaad, Indien, 500034
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New Delhi, Indien, 110029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italien, 20132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Udine, Italien, 33100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mexico City, Mexico, 04030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bydgoszcz, Polen, 85-822
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Katowice, Polen, 40-044
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Lublin, Polen, 20-081
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Poznan, Polen, 61-696
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Coimbra, Portugal, 3000-548
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Alicante, Spanien, 03015
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Barcelona, Spanien, 08022
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spanien, 28002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valladolid, Spanien, 47005
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Tao-Yuan, Taiwan, 333
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Leipzig, Tyskland, 04103
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Munster, Tyskland, 48145
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sulzbach, Tyskland, 66280
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ulm, Tyskland, D-89075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Type 1 eller Type 2 diabetes
- 18 år eller ældre
- Ikke-klinisk signifikant diabetisk makulaødem
- Mild til moderat diabetisk retinopati i undersøgelsesøjet, glaslegemeblødning i undersøgelsesøjet
- Relativt godt syn (20/30 eller bedre)
Ekskluderingskriterier:
- Operation eller laserbehandling i undersøgelsesøjet
- Grøn stær i undersøgelsesøjet
- Glykosyleret hæmoglobin (HbA1c) større end 11 % eller systolisk blodtryk større end 170 millimeter kviksølv (mmHg)
- Leversygdom, dialyse eller nyretransplantation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Ruboxistaurin
32 milligram (mg) én gang dagligt (QD) oralt i op til 36 måneder
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32 mg én gang dagligt (QD) oralt i op til 36 måneder
Andre navne:
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Placebo komparator: Placebo
QD oral i op til 36 måneder
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QD oral i op til 36 måneder
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gennemsnitlig varighed af bestemt center for macula-involveret diabetisk makulaødem (DME)
Tidsramme: 6 måneder til 36 måneder
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Varigheden af center of macula involvering, da det primære studieresultat (DME involvering i center of macula bestemt ved central gradering af stereoskopiske fundusfotografier) blev identificeret ved et besøg, blev deltageren anset for at have haft decideret centerinvolvering i et specificeret tidsrum mellem de tilstødende besøg.
Samlet varighed af centerinvolvering blev beregnet.
Gennemsnitsvarighed var den samlede varighed af centerinvolvering divideret med det samlede antal deltagere.
Deltagervarigheden blev opsummeret, det samlede antal måneder med centerinvolvering i begge behandlingsgrupper blev vist.
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6 måneder til 36 måneder
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Forekomst af vedvarende moderat visuelt tab (SMVL) i et diabetisk retinopati (DR) undersøgelsesøje
Tidsramme: Baseline, 36 måneder
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Forekomsten af SMVL blev defineret som et fald på ≥15 bogstaver fra baseline i det bedst korrigerede Early Treatment Diabetic Retinopathy Study (ETDRS) synsskarphed (VA) i ethvert DR-undersøgelsesøje i forhold til baseline, der er vedvarende i de sidste 6 måneders deltagelse.
ETDRS VA: Deltageren starter i toppen af diagrammet med 5 bogstaver pr. række og læser ned i diagrammet, indtil han når en række, hvor minimum 3 bogstaver på en linje ikke kan læses.
Deltageren scores efter, hvor mange bogstaver der kunne identificeres korrekt.
Et højere antal bogstaver, der er korrekt identificeret, repræsenterer bedre synsstyrke.
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Baseline, 36 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline i synsskarphed ved tidlig behandling Diabetisk retinopati undersøgelse (ETDRS) synsskarphed (VA) ved 36 måneder
Tidsramme: Baseline, 36 måneder
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ETDRS VA: Deltageren starter i toppen af diagrammet med 5 bogstaver pr. række og læser ned i diagrammet, indtil han når en række, hvor minimum 3 bogstaver på en linje ikke kan læses.
Deltageren scores efter, hvor mange bogstaver der kunne identificeres korrekt.
Et højere antal bogstaver, der er korrekt identificeret, repræsenterer bedre synsstyrke.
Resultater rapporteres baseret på antallet af diabetisk retinopati (DR) øjne.
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Baseline, 36 måneder
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Første forekomst af fokal/gitterfotokoagulation
Tidsramme: Baseline gennem 36 måneder
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Den første forekomst af fokal/gitterfotokoagulation uanset diabetisk makulaødem (DME) afstand fra midten af makula.
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Baseline gennem 36 måneder
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Skift fra baseline i kontrastfølsomhed af Pelli-Robson
Tidsramme: Baseline, 36 måneder
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Pelli-Robson diagram læst fra venstre mod højre + fra top til bund.
Hver linje har 2 grupper, hver på 3 bogstaver.
Bogstaver i hver gruppe har samme kontrast.
Kontrasten i hver efterfølgende gruppe er mindre end den foregående gruppe.
Deltageren læser bogstaver, der starter med højeste kontrast, fortsætter indtil 2 eller 3 bogstaver i 1 gruppe er forkert navngivet.
Scoret på tasten, der viser alle bogstaver i fuld kontrast, giver logkontrastens følsomhed svarende til hver gruppe.
Score bestemmes af forrige gruppe (sidste gruppe, hvor 2 eller 3 bogstaver var korrekt navngivet).
Resultater rapporteret baseret på antal DR øjne.
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Baseline, 36 måneder
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Progression of Nonproliferative Diabetic Retinopathy (DR) af Seven-field Stereo Fundus Photography
Tidsramme: Baseline gennem 36 måneder
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Deltagerne blev klassificeret som at have oplevet progression eller ingen progression af DR efter 36 måneders besøg.
Progression af DR=3 trin på ETDRS retinopati sværhedsgrad personskala for deltagere med begge øjne mindre end proliferativ diabetisk retinopati (PDR) ved baseline ELLER 2 trin på ETDRS retinopati sværhedsgrad øjenskala for deltagere med 1 øje mindre end PDR ved baseline ELLER anvendelse af panretinal laserterapi.
Deltagerne blev ved baseline tildelt ETDRS retinopati sværhedsgradsskala for personer eller individuelle øjne; bestemmelse af ingen progression/progression var afhængig af skalaen.
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Baseline gennem 36 måneder
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Ændring fra baseline i estimeret glomerulær filtreringshastighed
Tidsramme: Baseline, 36 måneder
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Modifikation af diæt ved nyresygdomme (MDRD) undersøgelsesformlen, der anvendes til bestemmelse af den estimerede glomerulære filtrationshastighed (eGFR) er: eGFR = 170 X (serumkreatininkoncentration [mg/deciliter (dL)])-0,999
X (Alder [år]) -0,176 X (0,762 hvis deltageren er kvinde) X (1,180 hvis deltageren er sort) X (serumurinstof nitrogenkoncentration [mg/dL])-0,170
X (serumalbuminkoncentration [gram (g)/dL])+0,318.
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Baseline, 36 måneder
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Skift fra baseline ved slutpunkt i albumin/kreatinin-forhold
Tidsramme: 36 måneder
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36 måneder
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Ændring fra baseline ved endepunkt i visuel funktion af National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) efter 36 måneder
Tidsramme: 36 måneder
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25 visionsmålrettede spørgsmål, der repræsenterer 11 visionsrelaterede konstruktioner og et 1-element generelt sundhedsvurderingsspørgsmål.
Måler indflydelsen af synshandicap og visuelle symptomer på generiske sundhedsdomæner såsom følelsesmæssigt velvære og social funktion og opgaveorienterede domæner relateret til daglig visuel funktion.
Hvert element konverteres til en skala fra 0 til 100, således at en højere score repræsenterer bedre funktion.
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36 måneder
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Antal deltagere med uønskede hændelser
Tidsramme: Baseline gennem 36 måneder
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Resuméer af alvorlige bivirkninger (SAE'er) og alle andre ikke-alvorlige bivirkninger (AE'er) findes i modulet Rapporterede bivirkninger.
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Baseline gennem 36 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2004
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
26. august 2004
Først indsendt, der opfyldte QC-kriterier
30. august 2004
Først opslået (Skøn)
31. august 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Øjensygdomme
- Sygdomme i det endokrine system
- Diabetiske angiopatier
- Diabetes komplikationer
- Diabetes mellitus
- Nethindedegeneration
- Nethindesygdomme
- Makuladegeneration
- Diabetisk retinopati
- Makulaødem
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Ruboxistaurin
Andre undersøgelses-id-numre
- 8211
- B7A-MC-MBDL (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .