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AzTrials

Geographic AtrophyPhase 3NCT02745119

Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

A Phase 3 study testing Lampalizumab in people with Geographic Atrophy, run by Hoffmann-La Roche at 208 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). Read more about this study

Who is it for?
Any age
Conditions the study is for
Geographic Atrophy
What is being tested?
Lampalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
994 participants
Where
208 sitesin 19 countries
Study dates
21 Jul 2016to 31 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
  • Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

Who cannot join

  • Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Increased risk of infection
  • Pregnancy or lactation

Trial locations and contacts

208 sites in 19 countries.

208 sites in 19 countries

United States122 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Lions Eye Institute

    Albany, New York, 12208

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Texas Retina Associates

    Arlington, Texas, 76012

  • West Carolina Retinal AssocPA

    Asheville, North Carolina, 28803

  • Retina & Vitreous Center of Southern Oregon

    Ashland, Oregon, 97520

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • University of Colorado

    Aurora, Colorado, 80045

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Vitreoretinal Associates of Washington

    Bellevue, Washington, 98004

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Uni of Alabama At Birmingham Clinical Research Unit

    Birmingham, Alabama, 35233

  • Retina Center of New Jersey

    Bloomfield, New Jersey, 07003

  • Tufts Medical Center Research

    Boston, Massachusetts, 02111

  • Mass Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Inst

    Boynton Beach, Florida, 33426

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Univ of Virginia Ophthalmology

    Charlottesville, Virginia, 22903

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey, 08034

  • Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Cleveland Clinic Foundation; Cole Eye Institute

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern

    Colorado Springs, Colorado, 80909

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Kresge Eye Institute

    Detroit, Michigan, 48201-1423

  • Duke University Eye Center; Vitreoretinal

    Durham, North Carolina, 27710

  • Vitreoretinal Surgery

    Edina, Minnesota, 55435

  • New Jersey Retina Research Foundation

    Edison, New Jersey, 8820

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Health Center

    Fort Myers, Florida, 33907

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institution

    Germantown, Tennessee, 38138

  • Colorado Retina Associates, PC

    Golden, Colorado, 80201

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Long Is. Vitreoretinal Consult

    Hauppauge, New York, 11788

  • Retina Consultants of Houston

    Houston, Texas, 77030

  • Midwest Eye Institute Northside

    Indianapolis, Indiana, 46290

  • Specialty Eye Institute

    Jackson, Michigan, 49202

  • UCSD Shiley Eye Center

    La Jolla, California, 92093-0946

  • Charleston Neuroscience Inst

    Ladson, South Carolina, 29456

  • Retina Consultants of Nevada

    Las Vegas, Nevada, 89123

  • Delaware Valley Retina Assoc

    Lawrenceville, New Jersey, 08648

  • Lahey Clinic Med Ctr

    Lexington, Kentucky, 02421

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • Opthalmic Consultants of LI

    Lynbrook, New York, 11563

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Valley Retina Institute P.A.

    McAllen, Texas, 78503

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

  • N CA Retina Vitreous Assoc

    Mountain View, California, 94040

  • Bascom Palmer Eye Institute

    Naples, Florida, 34103

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • Retina Group of New England

    New London, Connecticut, 06320

  • New York Eye & Ear Infirmary

    New York, New York, 10003

  • Vitreous-Retina-Macula

    New York, New York, 10022

  • Retinal & Ophthalmic Cons PC

    Northfield, New Jersey, 08225

  • East Bay Retina Consultants

    Oakland, California, 94609

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Bascom Palmer Eye Institute

    Palm Beach Gardens, Florida, 33418

  • Southern CA Desert Retina Cons

    Palm Desert, California, 92211

  • Byers Eye Insitute at Stanford

    Palo Alto, California, 94303

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04102

  • Retina Northwest

    Portland, Oregon, 97221

  • Oregon HSU; Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

    Richmond, Virginia, 23226

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Retina Assoc of Western NY

    Rochester, New York, 14620

  • Assoc Retinal Consultants PC

    Royal Oak, Michigan, 48073

  • University of California, Davis, Eye Center

    Sacramento, California, 95817

  • Retinal Consultants Med Group

    Sacramento, California, 95841

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • W Coast Retina Med Group Inc

    San Francisco, California, 94107

  • UCSF Comprehensive Cancer Ctr; Ophthalmology

    San Francisco, California, 94143

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Associates

    Shawnee Mission, Kansas, 66204

  • Retina Center Northwest

    Silverdale, Washington, 98383

  • Retina Consultants of Michigan

    Southfield, Michigan, 48034

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Retina Vit Surgeons/Central NY

    Syracuse, New York, 13224

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33612

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Scott and White Hospital

    Temple, Texas, 76504

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Specialists

    Towson, Maryland, 21204

  • Retina Centers P.C.

    Tucson, Arizona, 85704

  • Retina Associates Southwest PC

    Tucson, Arizona, 85750

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Virginia Retina Center

    Warrenton, Virginia, 20186

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Associates in Ophthalmology

    West Mifflin, Pennsylvania, 15122

  • Vitreo Retinal Consultants

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Wake Forest Baptist Health Eye Centre

    Winston-Salem, North Carolina, 27157

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Germany13 sites

  • Universitäts-Augenklinik Bonn

    Bonn, 53127

  • Universitätsklinikum Köln; Augenklinik

    Cologne, 50937

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hanover, 30625

  • Universitätsklinik Heidelberg; Augenklinik

    Heidelberg, 69120

  • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

    Ludwigshafen, 67063

  • LMU Klinikum der Universität, Augenklinik

    München, 80336

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149

  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

United Kingdom11 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN

  • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

    Liverpool, L7 8XP

  • Macular Treatment Centre; Royal Eye Hospital

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV10 0QP

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Spain10 sites

  • Hospital Perpetuo Socorro; Servicio de Oftalmología

    Albacete, 02006

  • Institut de la Macula i la retina

    Barcelona, 08022

  • Instituto de microcirugia ocular

    Barcelona, 08035

  • Instituto Clinico Quirurgico de Oftalmologia - ICQO

    Bilbao, Guipuzcoa, 48006

  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia

    L'Hospitalet de Llobregat, Barcelona, 8907

  • VISSUM Madrid Santa Hortensia

    Madrid, 28002

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarre, 31008

  • Instituto Oftalmologico Gomez Ulla

    Santiago de Compostela, LA Coruña, 15706

  • FISABIO. Fundación Oftalmologica del Mediterraneo

    Valencia, 46015

  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia

    Valladolid, 47012

Other trials in Spain

France7 sites

  • Hopital Pellegrin; Ophtalmologie

    Bordeaux, 33000

  • Chi De Creteil; Ophtalmologie

    Créteil, 94010

  • Hôpital de La Croix Rousse

    Lyon, 69004

  • Centre Monticelli Paradis d Ophtalmologie

    Marseille, 13008

  • CHU Nantes - Hôtel Dieu; Ophthalmology

    Nantes, 44093

  • Centre Odeon; Exploration Ophtalmologique

    Paris, 75006

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012

Other trials in France

Poland7 sites

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki

    Bytom, 41-902

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501

  • Klinika Okulistyczna Jasne Błonia

    Lodz, 91-134

  • Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

    Wroclaw, 50-556

Other trials in Poland

Australia6 sites

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640

  • Vision Eye Institute Eastern

    Box Hill, Victoria, 3128

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria, 3002

  • Marsden Eye Research Centre

    Parramatta, New South Wales, 2150

  • Save Sight Institute

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

Italy6 sites

  • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

    Genoa, Liguria, 16132

  • Irccs Ospedale San Raffaele;U.O. Oculistica

    Milan, Lombardy, 20132

  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    Milan, Lombardy, 20157

  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

    Rome, Lazio, 00133

  • A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

    Turin, Piedmont, 10122

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

    Udine, Veneto, 33100

Other trials in Italy

Hungary5 sites

  • Semmelweis Egyetem AOK, Szemeszeti Klinika

    Budapest, 1083

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

    Budapest

  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

    Debrecem, 4032

  • Ganglion Medial Center

    Pécs, 7621

Other trials in Hungary

Slovakia4 sites

  • Nemocnica sv. Michala, a.s.

    Bratislava, 81108

  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

    Bratislava, 851 07

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín, 911 71

  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

    Žilina, 012 07

Other trials in Slovakia

Portugal3 sites

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548

  • Espaco Medico Coimbra

    Coimbra, 3030-163

  • Hospital de Santa Maria; Servico de Oftalmologia

    Lisbon, 1649-035

Other trials in Portugal

Switzerland3 sites

  • Inselspital Bern, Universitätsklinik für Augenheilkunde

    Bern, 3010

  • Vista Klinik Binningen

    Binningen, 4102

  • Stadtspital Triemli; Augenklinik

    Zurich, 8063

Other trials in Switzerland

Austria2 sites

  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

    Linz, 4021

  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • UZ Leuven Sint Rafael

    Leuven, 3000

Other trials in Belgium

Denmark2 sites

  • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

    Glostrup Municipality, 2600

  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen

    Roskilde, 4000

Other trials in Denmark

Turkey (Türkiye)2 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Baskent University Ankara Hospital

    Ankara, 06490

Other trials in Turkey (Türkiye)

Canada1 site

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 1S6

Other trials in Canada

Netherlands1 site

  • Leids Universitair Medisch Centrum

    Leiden, 2300 RC

Other trials in Netherlands

Peru1 site

  • TG Laser Oftalmica

    Lima, 27

Other trials in Peru

About this study

Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

Being tested
Lampalizumab
Medical subject headings
Geographic Atrophy

What participants receive

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

  • LampalizumabDrug

    Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.

Study groups in NCT02745119
Study groupRoleWhat they receive
Lampalizumab Every 4 WeeksExperimentalParticipants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.
Receives: Drug: Lampalizumab
Lampalizumab Every 6 WeeksExperimentalParticipants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.
Receives: Drug: Lampalizumab

What is being measured

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

  1. Percentage of Participants With Ocular Adverse Events (AEs) by Severity

    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.

    Measured: Up to approximately one year

  2. Percentage of Participants With Systemic (Non-Ocular) AEs by Severity

    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.

    Measured: Up to approximately one year

  3. Percentage of Participants With Anti-Lampalizumab Antibodies

    The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.

    Measured: Week 48

Timeline

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

  1. First posted20 Apr 2016 (estimated)
  2. Study start21 Jul 2016
  3. Primary completion31 Jan 2018
  4. Study completion31 Jan 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
994 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02745119
Sponsor's protocol ID
GX30191
Other IDs
2016-000423-13, 2016
Status last verified
Jan 2019
First submitted
18 Apr 2016
Last updated
6 Mar 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lampalizumab in people with Geographic Atrophy, run by Hoffmann-La Roche at 208 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, Germany, United Kingdom, Spain, France 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. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Ocular Adverse Events (AEs) by Severity (time frame: Up to approximately one year). The study lists 3 primary outcomes in all. 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 NCT02745119.

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 6 Mar 2019.

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