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Diabetes Mellitus, Type 2Phase 3FOCUSNCT03811561

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 230 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,500 participants
Where
230 sitesin 19 countries
Study dates
8 May 2019to 7 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
  • Eye inclusion criteria (both eyes must meet all criteria):
  • Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
  • No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
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  • No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
  • Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
  • No previous treatment with pan-retinal laser photocoagulation
  • No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
  • No substantial media opacities that would preclude successful imaging

Who cannot join

  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
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  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
  • Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
  • Receipt of any investigational medicinal product within 30 days before screening
  • Previous participation in this trial. Participation is defined as randomisation
  • Known or suspected hypersensitivity to trial products or related products
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Trial locations and contacts

230 sites in 19 countries.

230 sites in 19 countries

United States72 sites

  • Lovelace Scientific Resources Inc

    Albuquerque, New Mexico, 87108

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Michigan Medicine

    Ann Arbor, Michigan, 48105

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • Rocky Mount Reg VA Med-DN

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731

  • American Health Network of Indiana, LLC_Avon

    Avon, Indiana, 46123

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center_Cary

    Boston, Massachusetts, 02118

  • Joslin Center For Diabetes

    Boston, Massachusetts, 02215

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Holston Medical Group Pc

    Bristol, Tennessee, 37620-7352

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28226

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • Diabetes & Endo Specialists Inc

    Chesterfield, Missouri, 63017

  • Apex Medical Research Inc

    Chicago, Illinois, 60607

  • The University Of Chicago

    Chicago, Illinois, 60637

  • Innovative Research of W FL

    Clearwater, Florida, 33756

  • Southern California Res Ctr

    Coronado, California, 92118

  • FDRC

    Costa Mesa, California, 92627

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • American Health Network of Indiana, LLC_Greenfield

    Greenfield, Indiana, 46140

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • Est Cst Inst for Rsrch,Jksnvil

    Jacksonville, Florida, 32216

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • VA Medical Center

    Lexington, Kentucky, 40502

  • Kentucky Diabetes-Endocrinology Center

    Lexington, Kentucky, 40503

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • Angel City Research, Inc.

    Los Angeles, California, 90010

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175

  • Riverside University Health System Medical Center

    Moreno Valley, California, 92555

  • Synexus Clinical Research US, INC.

    Murray, Utah, 84107

  • Southern New Hampshire Diabete

    Nashua, New Hampshire, 03060

  • Vanderbilt Diab Obes Clin Tri

    Nashville, Tennessee, 37212

  • NYC Research, Inc.

    New York, New York, 10016

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Harold Hamm Diabetes Center

    Oklahoma City, Oklahoma, 73104

  • Four Rivers Clinical Research Inc

    Paducah, Kentucky, 42001

  • Aria Endocrine Metabolic Assoc

    Philadelphia, Pennsylvania, 19114

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114

  • Synexus Rsch /Cnt Phnx Med C

    Phoenix, Arizona, 85050

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730-3063

  • Synexus Clinical Research US, Inc._Tempe_0

    Richfield, Minnesota, 55432

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • VIP Trials

    San Antonio, Texas, 78230

  • UCLA Diabetes Center at Santa Monica

    Santa Monica, California, 90404

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • MultiCare Inst for Res & Innov

    Spokane, Washington, 99202

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • South Arizona VA Healthcare System

    Tucson, Arizona, 85723

  • Synexus Cln Rsrch Inc - Orange Gro FP

    Tucson, Arizona, 85741

  • Coastal Metabolic Research Center

    Ventura, California, 93003

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

Other trials in United States

India25 sites

  • All India Institute of Medical Sciences

    Ansari Nagar, New Delhi 110029, New Delhi, 110029

  • Narayana Hrudayalya Institute of Cardiac Sciences

    Bangalore, Karnataka, 560 099

  • Diacon Hospital Private Limited

    Bangalore, Karnataka, 560010

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Apollo Hospital

    Delhi, New Delhi, 110076

  • Indraprastha Apollo Hospital

    Delhi, New Delhi, 110076

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

  • Care Hospital

    Hyderabad, 600034

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • SSKM

    Kolkata, West Bengal, 700020

  • Apollo Gleneagles Hospital

    Kolkata, West Bengal, 700054

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

  • Dayanand Medical College & Hospital_Ludhiana

    Ludhiana, Punjab, 141001

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu, 625 020

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Aditya Jyot Hospital

    Mumbai, 400031

  • Government Medical College and Super Speciality Hospital, Nagpur

    Nagpur, Maharashtra, 440009

  • DEW Medicare & Trinity hospital

    Nagpur, Maharashtra, 440015

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Indian Institute of Diabetes

    Thiruvananthapuram, Kerala, 695031

  • Indian Institute of Diabetes

    Thiruvnanthapuram, Kerala, 695033

Other trials in India

Poland16 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • In-Vivo Sp. z o.o.

    Bydgoszcz, 85-048

  • B_Serwis Popenda Sp.J.

    Chorzów, 41-500

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Clinical Medical Research Korfantego - Ambulatoryjna Opieka

    Katowice, 40-156

  • FutureMeds Sp. z o.o.

    Krakow, 31-501

  • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338

  • Prywatny Gabinet Lekarski Jan Ruxer

    Lodz, 94-047

  • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, Łódź Voivodeship, 90-302

  • SPZZOZ im. Marszalka J. Pilsudskiego w Plonsku

    Płońsk, 09-100

  • NZOZ "DiabMed" Poradnia Diabetologiczna

    Poznan, 60-821

  • Maciej Wiza Gaja Poradnie Lekarskie

    Poznan, 61-251

  • SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze

    Zabrze, 41-800

Other trials in Poland

Russia15 sites

  • Multispecialty Medical Clinic Anturium LLC

    Barnaul, 656043

  • Kazan Federal University

    Kazan', 420012

  • PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways

    Kazan', 420061

  • Kazan Federal University

    Kazan', 420097

  • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

    Moscow, 117292

  • National Medical Research Center of Endocrinology

    Moscow, 117292

  • Branch of limited liability company "Hadassah Medical LTD"

    Moscow, 143026

  • State Novosibirsk regional clinical hospital

    Novosibirsk, 630087

  • City Consultative & Diagnostic Centre #1

    Saint Petersburg, 194354

  • Diagnistic Centre "Energo"

    Saint Petersburg, 196084

  • Consultative & Diagnostic Center with a Outpatient Hospital

    Saint Petersburg, 197110

  • Llc "International Medical Center "Time"

    Saint-Peterburg, 194044

  • SHI Saratov City Clinical Hospital #9

    Saratov, 410031

  • Regional clinical cardiology dispensary

    Saratov, 410039

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Bulgaria12 sites

  • DCC I- Pleven EOOD Endocrinology

    Pleven, 5801

  • MHAT Sveti Pantaleimon - Pleven, Internal Diseases

    Pleven, 5806

  • MHAT Med Line Clinic

    Plovdiv, 4000

  • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology

    Plovdiv, 4002

  • MHAT MC-Sv Ivan Rilski EOOD

    Plovdiv, 4003

  • "DCC VII - Sofia", Endocrinology Consulting Room

    Sofia, 1233

  • DCC VII - Sofia EOOD, Endocrinology

    Sofia, 1233

  • MHAT Knyaginya Klementina - Sofia EAD

    Sofia, 1233

  • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

    Sofia, 1431

  • IV MHAT - Sofia EAD

    Sofia, 1606

  • DCC XX - Sofia EOOD, Endocrinology

    Sofia, 1618

  • Medical centre Vitclinic EOOD

    Sofia, 1680

Other trials in Bulgaria

United Kingdom10 sites

  • Harrogate District Hospital

    Harrogate, North Yorkshire, HG2 7SX

  • King's College Hospital

    London, SE5 9RS

  • Norfolk and Norwich University Hospital

    Norfolk, NR4 7UQ

  • Queen's Medical Centre University Hospital

    Nottingham, Nottinghamshire, NG7 2UH

  • University Hospital, Queens Medical Centre

    Nottingham, Nottinghamshire, NG7 2UH

  • George Eliot Hospital NHS Trust

    Nuneaton, CV10 7DJ

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

  • Clinical Research Unit

    Somerset, BA21 4AT

  • Royal Cornwall Hospital (Treliske)

    Truro, TR1 3LJ

  • Yeovil Hospital

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Canada9 sites

  • LMC Clinical Res Thornhill

    Concord, Ontario, L4K 4M2

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1

  • LMC Endo Ctr (Etobicoke) Ltd

    Etobicoke, Ontario, M9R 4E1

  • LMC Clinical Research, Inc. (Montreal Glen)

    Montreal, Quebec, H4A 2C6

  • LMC Oakville

    Oakville, Ontario, L6M 1M1

  • The Ottawa Hospital Riverside Campus

    Ottawa, Ontario, K1H7W9

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • LMC Clin Rsrch Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • LMC Endo Centres Ltd.(Bayview)

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Germany9 sites

  • Praxis Denger/Pfitzner, Friedrichsthal

    Friedrichsthal, 66299

  • Diabetologische Schwerpunktpraxis Harburg- Dr. med.Paschen,

    Hamburg, 21073

  • Diabetes-Zentrum-Wilhelmsburg GbR

    Hamburg, 21109

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • Wendisch/Dahl Hamburg

    Hamburg, 22607

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Greece9 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

  • "Laiko" General Hospital of Athens

    Athens, 11527

  • "Laiko" General Hospital of Athens

    Athens, GR-11527

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, GR-17562

  • University Hospital of Athens ATTIKON

    Haidari-Athens, GR-12462

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642

  • "Thermi" Private Hosital

    Thessaloniki, 57001

  • "Thermi" Private Hosital

    Thessaloniki, GR-57001

Other trials in Greece

Portugal9 sites

  • ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267

  • ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro

    Aveiro, 3814-501

  • Unidade De Coimbra, E.P.E. - Hospital da Universidade de Coimbra

    Coimbra, 3000-561

  • ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães

    Guimarães, 4835-044

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-230

  • Centro Hospitalar de São João

    Porto, 4200-319

  • ULS De São João, E.P.E. - Hospital de São João

    Porto, 4200-319

  • ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513

  • ULS Da Arrábida, E.P.E._Hospital de São Bernardo

    Setúbal, 2910-446

Other trials in Portugal

Romania7 sites

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucharest, 020475

  • "Carol Davila" Military Emergency Hospital

    Bucharest, 010825

  • Sana Monitoring SRL

    Bucharest, 011025

  • SC Clinica Diabnutrimed S.R.L.

    Bucharest, 020359

  • Clinic of Diabetes Cluj

    Cluj-Napoca, Cluj, 400006

  • SC Centru Medical Dr. Negrisanu SRL

    Timișoara, Timiș County, 300456

  • 3rd Clinic for Nutrition-Spitalulul Județean de Urgenta

    Timișoara, Timiș County, 300736

Other trials in Romania

Spain7 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Virgen de la Macarena

    Seville, 41009

  • Hospital La Fe - Endocrinología y Nutrición

    Valencia, 46026

  • Hospital La Fe_Endocrinología y Nutrición

    Valencia, 46026

Other trials in Spain

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Diabetologie Krupska

    Prague, 100 00

  • Fakultni nemocnice Kralovske Vinohrady_Praha

    Prague, 100 34

  • Institut klinicke a experimentalni mediciny

    Prague, 140 00

  • MUDr. Michala Pelikanova

    Prague, 140 00

Other trials in Czechia

Israel6 sites

  • Rambam MC - Diabetes and obesity center of excellence

    Haifa, 31096

  • Hadassah Ein Karam MC - Diabetes Unit

    Jerusalem, 91120

  • Meir MC - Diabetes unit

    Kfar Saba, 44281

  • Rabin MC Beilinson - Endo unit

    Petah Tikva, 49100

  • Sourasky MC - Institute of Endocrinology, metabolism and hypertension

    Tel Aviv, 64239

  • Sheba MC - Endocrinology Clinic

    Tel HaShomer, 52621

Other trials in Israel

Latvia5 sites

  • Zemgales diabetes centre

    Jelgava, 3001

  • Teterovska practice

    Ogre, 5001

  • P. Stradins Clinical University Hospital

    Riga, 1002

  • Medical Centre Pulss 5

    Riga, 1011

  • Juglas Medicine Center

    Riga, LV-1024

Other trials in Latvia

Serbia5 sites

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Centre Nis, Endocrinology, Diabetes and Metabolism

    Niš, 18000

  • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Slovakia5 sites

  • V. interna klinika LF UK a UNB

    Bratislava, 82606

  • Nemocnica akademika L. Derera, UNB

    Bratislava, 833 05

  • Diabetologicka ambulancia, Dia Zilina s.r.o.

    Žilina, 01001

  • Medivasa s.r.o., Diabetologicka ambulancia

    Žilina, 01001

  • MEDIVASA, s.r.o., Diabetologicka ambulancia

    Žilina, 01001

Other trials in Slovakia

Mexico2 sites

  • Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

    Distrito Federal, México, D.F., 14080

  • Hospital Universitario Dr. José Eleuterio González_Monterrey

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Brazil1 site

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

About this study

Official title: Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

Being tested
Semaglutide, Placebo (semaglutide)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

  • Placebo (semaglutide)Drug

    Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Study groups in NCT03811561
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorParticipants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
Receives: Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.

    Percentage of subjects (yes/no).

    Measured: Year 5

Secondary outcomes (21)

  1. 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.

    Measured: Up to 5 years

  2. Change in visual acuity in the worse seeing eye.

    Measured in number of letters using the ETDRS protocol.

    Measured: Week 0, Year 5

  3. Change in visual acuity in the better seeing eye.

    Measured in number of letters using the ETDRS protocol.

    Measured: Week 0, Year 5

  4. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.

    Percentage of subjects (yes/no).

    Measured: Week 0-Year 5

  5. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.

    Percentage of subjects (yes/no).

    Measured: Week 0-Year 5

  6. 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).

    Measured: Week 0-Year 5

  7. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.

    Percentage of subjects (yes/no).

    Measured: Week 0-Year 5

  8. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.

    Percentage of subjects (yes/no).

    Measured: Week 0-Year 5

  9. Presence of at least 3 steps ETDRS subject level improvement.

    Percentage of subjects (yes/no).

    Measured: Year 5

  10. Presence of at least 2 steps ETDRS subject level progression.

    Percentage of subjects (yes/no).

    Measured: Year 5

  11. Presence of at least 2 steps ETDRS subject level improvement.

    Percentage of subjects (yes/no).

    Measured: Year 5

  12. Presence of persistent visual acuity up to 38 ETDRS letters in either eye.

    Percentage of subjects (yes/no).

    Measured: Year 5

  13. Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.

    Percentage of subjects (yes/no).

    Measured: Year 5

  14. Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.

    Percentage of subjects (yes/no).

    Measured: Year 5

  15. Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.

    Percentage of subjects (yes/no).

    Measured: Year 5

  16. Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.

    Percentage of subjects (yes/no).

    Measured: Year 5

  17. Presence of ciDME in either eye.

    Percentage of subjects (yes/no).

    Measured: Year 5

  18. Change in glycosylated haemoglobin (HbA1c).

    Measured in %-points.

    Measured: Week 0, Year 5

  19. Change in body weight.

    Measured in kg.

    Measured: Week 0, Year 5

  20. Change in systolic and diastolic blood pressure.

    Measured in mmHg.

    Measured: Week 0, Year 5

  21. Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.

    Measured in mmol/L

    Measured: Week 0, Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start8 May 2019
  3. Primary completion7 Nov 2027 (estimated)
  4. Study completion7 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811561
Sponsor's protocol ID
NN9535-4352
Other IDs
U1111-1201-6256, 2017-003619-20, 2017
Acronym
FOCUS
Status last verified
Oct 2026
First submitted
18 Jan 2019
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Ntentakis DP, Correa VSMC, Ntentaki AM, Vavvas DG. Differences in effects of some newer-generation anti-diabetics on diabetic retinopathy versus nephropathy. Graefes Arch Clin Exp Ophthalmol. 2024 Apr;262(4):1371-1372. doi: 10.1007/s00417-023-06353-1. Epub 2024 Jan 10. No abstract available.

    PubMed 38197991

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 230 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in United States, India, Poland, Russia, Bulgaria and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. (time frame: Year 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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