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Clinical Trial Details

Trial ID: L6658
Source ID: NCT03811561
Associated Drug: Semaglutide
Title: A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Acronym: FOCUS
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression., Percentage of subjects (yes/no)., Year 5 | Secondary: Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye., Measured in months., Up to 5 years|Change in visual acuity in the worse seeing eye., Measured in number of letters using the ETDRS protocol., Week 0, Year 5|Change in visual acuity in the better seeing eye., Measured in number of letters using the ETDRS protocol., Week 0, Year 5|Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation., Percentage of subjects (yes/no)., Week 0-Year 5|Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation., Percentage of subjects (yes/no)., Week 0-Year 5|Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF)., Percentage of subjects (yes/no)., Week 0-Year 5|Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid., Percentage of subjects (yes/no)., Week 0-Year 5|Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy., Percentage of subjects (yes/no)., Week 0-Year 5|Presence of at least 3 steps ETDRS subject level improvement., Percentage of subjects (yes/no)., Year 5|Presence of at least 2 steps ETDRS subject level progression., Percentage of subjects (yes/no)., Year 5|Presence of at least 2 steps ETDRS subject level improvement., Percentage of subjects (yes/no)., Year 5|Presence of persistent visual acuity up to 38 ETDRS letters in either eye., Percentage of subjects (yes/no)., Year 5|Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline., Percentage of subjects (yes/no)., Year 5|Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline., Percentage of subjects (yes/no)., Year 5|Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline., Percentage of subjects (yes/no)., Year 5|Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline., Percentage of subjects (yes/no)., Year 5|Presence of ciDME in either eye., Percentage of subjects (yes/no)., Year 5|Change in glycosylated haemoglobin (HbA1c)., Measured in %-points., Week 0, Year 5|Change in body weight., Measured in kg., Week 0, Year 5|Change in systolic and diastolic blood pressure., Measured in mmHg., Week 0, Year 5|Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides., Measured in mmol/L, Week 0, Year 5
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-05-08
Completion Date: 2027-11-07
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Del Sol Research Management, LLC, Tucson, Arizona, 85715, United States|Southern California Res Ctr, Coronado, California, 92118, United States|FDRC, Costa Mesa, California, 92627, United States|Diabetes/Lipid Mgmt & Res Ctr, Huntington Beach, California, 92648, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Torrance Clin Res Inst, Inc., Lomita, California, 90717, United States|Downtown LA Res Ctr. Inc., Los Angeles, California, 90017, United States|Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, 91730-3063, United States|Clinical Trials Research_Sacramento_0, Sacramento, California, 95821, United States|Coastal Metabolic Research Center, Ventura, California, 93003, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|Rocky Mount Reg VA Med-DN, Aurora, Colorado, 80045, United States|Chase Medical Research LLC, Waterbury, Connecticut, 06708, United States|Innovative Research of W FL, Clearwater, Florida, 33756, United States|Est Cst Inst for Rsrch,Jksnvil, Jacksonville, Florida, 32216, United States|Renstar Medical Research, Ocala, Florida, 34471, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|Apex Medical Research Inc, Chicago, Illinois, 60607, United States|The University Of Chicago, Chicago, Illinois, 60637, United States|American Health Network of Indiana, LLC_Avon, Avon, Indiana, 46123, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|Kentucky Diabetes-Endocrinology Center, Lexington, Kentucky, 40503, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Four Rivers Clinical Research Inc, Paducah, Kentucky, 42001, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States|Boston Medical Center_Cary, Boston, Massachusetts, 02118, United States|Joslin Center For Diabetes, Boston, Massachusetts, 02215, United States|Michigan Medicine, Ann Arbor, Michigan, 48109, United States|University of New Mexico, Albuquerque, New Mexico, 87131, United States|NYC Research, Inc., New York, New York, 10016, United States|Mountain Diabetes & Endocrine Center, Asheville, North Carolina, 28803, United States|OnSite Clinical Solutions, LLC, Charlotte, North Carolina, 28226, United States|Harold Hamm Diabetes Center, Oklahoma City, Oklahoma, 73104, United States|Tristar Clin Investigations, PC, Philadelphia, Pennsylvania, 19114, United States|Holston Medical Group Pc, Bristol, Tennessee, 37620-7352, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Vanderbilt Diab Obes Clin Tri, Nashville, Tennessee, 37212, United States|Central Texas Clinical Research, Austin, Texas, 78705, United States|Texas Diab & Endo, P.A., Austin, Texas, 78731, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|Clinical Trials of Texas, LLC, San Antonio, Texas, 78229, United States|VIP Trials, San Antonio, Texas, 78230, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|MultiCare Inst for Res & Innov, Spokane, Washington, 99202, United States|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|DCC I- Pleven EOOD, Pleven, 5801, Bulgaria|MHAT Sveti Pantaleimon - Pleven, Internal Diseases, Pleven, 5806, Bulgaria|MHAT "Med Line Clinic", Plovdiv, 4000, Bulgaria|UMHAT "Sveti Georgi", Clinic of Endocr. and Metab. Diseases, Plovdiv, 4002, Bulgaria|MHAT MC-Sv Ivan Rilski EOOD, Plovdiv, 4003, Bulgaria|"DCC VII - Sofia", Endocrinology Consulting Room, Sofia, 1233, Bulgaria|MHAT "Knyaginya Klementina" -Sofia EAD, Sofia, 1233, Bulgaria|USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology, Sofia, 1431, Bulgaria|"Fourth MHAT-Sofia EAD", Sofia, 1606, Bulgaria|"DCC XX - Sofia" EOOD, Endocrinology Consulting Room, Sofia, 1618, Bulgaria|Medical centre Vitclinic EOOD, Sofia, 1618, Bulgaria|Alberta Diabetes Institute, Edmonton, Alberta, T6G 2E1, Canada|LMC Clinical Res Thornhill, Concord, Ontario, L4K 4M2, Canada|LMC Endo Ctr (Etobicoke) Ltd, Etobicoke, Ontario, M9R 4E1, Canada|LMC Endo Centres Ltd.(Bayview), Toronto, Ontario, M4G 3E8, Canada|Centricity Res Pointe-Claire, Pointe-Claire, Quebec, H9R 4S3, Canada|LMC Clin Rsrch Inc. (Montreal), Saint-Laurent, Quebec, H4T 1Z9, Canada|Fakultni nemocnice Brno, Brno, 62500, Czechia|Fakultni nemocnice Hradec Kralove, Hradec Kralove, 500 05, Czechia|Diabetologie Krupska, Praha 10, 100 00, Czechia|Institut klinicke a experimentalni mediciny, Praha 4, 140 00, Czechia|MUDr. Michala Pelikanova, Praha 4, 140 00, Czechia|Fakultni nemocnice Kralovske Vinohrady_Praha, Praha, 100 34, Czechia|Denger, Friedrichsthal, Friedrichsthal, 66299, Germany|Diabetes-Zentrum-Wilhelmsburg GbR, Hamburg, 21109, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin, Münster, 48153, Germany|Praxis Dr. med. Wenzl-Bauer, Rehlingen-Siersburg, 66780, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|University Hospital of Athens ATTIKON, Athens, Attica, 12462, Greece|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|"Laiko" General Hospital of Athens, Athens, 11527, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, GR-17562, Greece|University Hospital of Athens ATTIKON, Haidari-Athens, GR-12462, Greece|"Ippokrateio" G.H. of Thessaloniki, Thessaloniki, 54642, Greece|"Thermi" Private Hosital, Thessaloniki, 57001, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|Narayana Hrudayalya Institute of Cardiac Sciences, Bangalore, Karnataka, 560 099, India|Diacon Hospital Private Limited, Bangalore, Karnataka, 560010, India|Amrita Institute Of Medical Sciences & Research Centre, Kochi, Kerala, 682041, India|Indian Institute of Diabetes, Thiruvananthapuram, Kerala, 695031, India|BYL Nair Hospital and T N Medical College Department of endo, Mumbai, Maharashtra, 400008, India|Government Medical College and Super Speciality Hospital, Nagpur, Nagpur, Maharashtra, 440003, India|Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, 411004, India|All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, New Delhi, 110029, India|Apollo Hospital, Delhi, New Delhi, 110076, India|Indraprastha Apollo Hospital, Delhi, New Delhi, 110076, India|Christian Medical College and Hospital, Ludhiana, Punjab, 141008, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Arthur Asirvatham hospital,, Madurai, Tamil Nadu, 625 020, India|SSKM, Kolkata, West Bengal, 700020, India|Apollo Gleneagles Hospital, Kolkata, West Bengal, 700054, India|Care Hospital, Hyderabad, 600034, India|Diabetes and obesity center of excellence, Rambam MC, Haifa, 31096, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Clinical Research Unit Meir Medical Center, Kfar Saba, 44281, Israel|Rabin MC Beilinson Campus Endo, Petah-Tikva, 49100, Israel|Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer, 52621, Israel|Institute of Endocrinology, metabolism and hypertension, Tel-Aviv, 64239, Israel|Zemgales diabetes centre, Jelgava, 3001, Latvia|Teterovska practice, Ogre, 5001, Latvia|Medical Centre Pulss 5, Riga, 1011, Latvia|P. Stradins Clinical University Hospital, Riga, LV-1002, Latvia|Juglas Medicine Center, Riga, LV-1024, Latvia|Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab, Distrito Federal, México, D.F., 14080, Mexico|Hospital Universitario Dr. José Eleuterio González_Monterrey, Monterrey, Nuevo León, 64460, Mexico|Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Podlaskie Voivodeship, 15-276, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, Wojewodztwo Lodzkie, 90-302, Poland|In-Vivo Sp. z o.o., Bydgoszcz, 85-048, Poland|B_Serwis Popenda Sp.J., Chorzow, 41-500, Poland|Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gdansk, 80-382, Poland|NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o., Gdansk, 80-858, Poland|Centrum Medyczne Pratia Katowice, Katowice, 40-081, Poland|FutureMeds Sp. z o.o., Kraków, 31-501, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, 90-302, Poland|Prywatny Gabinet Lekarski Jan Ruxer, Lodz, 94-047, Poland|NZOZ "DiabMed" Poradnia Diabetologiczna, Poznan, 60-821, Poland|Gaja Poradnie Lekarskie, Poznan, 61-251, Poland|SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze, Zabrze, 41-800, Poland|Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal|Unidade Local De Saude De Almada-Seixal E.P.E., Almada, 2805-267, Portugal|Unidade Local De Saude Da Regiao De Aveiro E.P.E., Aveiro, 3814-501, Portugal|Unidade Local de Saúde de Coimbra, E.P.E., Coimbra, 3000-561, Portugal|Unidade Local de Saude do Alto Ave, E.P.E., Guimarães, 4835-044, Portugal|APDP - Associação Protectora dos Diabéticos de Portugal, Lisboa, 1250-230, Portugal|Centro Hospitalar de São João, Porto, 4200-319, Portugal|Unidade Local de Saude de Sao Joao E.P.E, Porto, 4200-319, Portugal|Unidade Local de Saúde da Arrábida, E.P.E., Setubal, 2910-446, Portugal|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|Clinic of Diabetes Cluj, Cluj Napoca, Cluj, 400006, Romania|3rd Clinic for Nutrition-Spitalulul Județean de Urgenta, Timisoara, Timis, 300736, Romania|"Carol Davila" Military Emergency Hospital, Bucharest, 010825, Romania|Sana Monitoring SRL, Bucharest, 011025, Romania|SC Clinica Diabnutrimed S.R.L., Bucharest, 020358, Romania|Multispecialty Medical Clinic Anturium LLC, Barnaul, 656043, Russian Federation|Kazan Federal University, Kazan, 420012, Russian Federation|PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways, Kazan, 420061, Russian Federation|National Medical Research Center of Endocrinology, Moscow, 117292, Russian Federation|City Consultative & Diagnostic Centre #1, Saint-Petersburg, 194354, Russian Federation|Diagnistic Centre "Energo", Saint-Petersburg, 196084, Russian Federation|Consultative & Diagnostic Center with a Outpatient Hospital, Saint-Petersburg, 197110, Russian Federation|SHI Saratov City Clinical Hospital #9, Saratov, 410031, Russian Federation|Regional clinical cardiology dispensary, Saratov, 410039, Russian Federation|CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia|Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade, 11000, Serbia|Clinical Hospital Center Bezanijska Kosa, Belgrade, 11080, Serbia|Clinical Centre Nis, Endocrinology, Diabetes and Metabolism, Nis, 18000, Serbia|Nemocnica akademika L. Derera, UNB, Bratislava, 833 05, Slovakia|Diabetologicka ambulancia, Dia Zilina s.r.o., Zilina, 01001, Slovakia|Medivasa s.r.o., Diabetologicka ambulancia, Zilina, 01001, Slovakia|MEDIVASA, s.r.o., Diabetologicka ambulancia, Zilina, 01001, Slovakia|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital de Bellvitge, Hospitalet de Llobregat, 08907, Spain|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|Clinica Universitaria de Navarra, Pamplona, 31008, Spain|Hospital Virgen de la Macarena, Sevilla, 41009, Spain|Hospital La Fe - Endocrinología y Nutrición, Valencia, 46026, Spain|Harrogate District Hospital, Harrogate, North Yorkshire, HG2 7SX, United Kingdom|University Hospital, Queens Medical Centre, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom|Kings College Hospital, London, SE5 9RS, United Kingdom|The Norfolk and Norwich University Hospital, Norfolk, NR4 7UQ, United Kingdom|Harrogate District Hospital, North Yorkshire, HG2 7SX, United Kingdom|George Eliot Hospital NHS Trust, Nuneaton, CV10 7DJ, United Kingdom|Clinical Research Unit, Somerset, BA21 4AT, United Kingdom|Royal Cornwall Hospital (Treliske), Truro, TR1 3LJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03811561

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress