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AzTrials

Macular DegenerationPhase 3NCT02462486

Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

A Phase 3 study testing Abicipar Pegol and Ranibizumab in people with Macular Degeneration, run by Allergan at 187 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Abicipar Pegol and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
949 participants
Where
187 sitesin 16 countries
Study dates
25 Jun 2015to 6 Jun 2019
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of age-related macular degeneration in at least 1 eye
  • Best corrected visual acuity of 20/40 to 20/320 in the study eye
  • Best corrected visual acuity of 20/200 or better in the non-study eye

Who cannot join

  • History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
  • Cataract or refractive surgery in the study eye within the last 3 months

Trial locations and contacts

187 sites in 16 countries.

187 sites in 16 countries

United States73 sites

  • Win Retina

    Arcadia, California, 91006

  • Retina Institute of California

    Arcadia, California, 91007

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina, 28803

  • Retina & Vitreous Center SO, PC

    Ashland, Oregon, 97520

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina Associates of Cleveland, Inc

    Beachwood, Ohio, 44122

  • Retina and Vitreous of Texas

    Beaumont, Texas, 77707

  • Vitreoretinal Associates of Washington

    Bellevue, Washington, 98004

  • Eye Foundation Hospital

    Birmingham, Alabama, 35233

  • Retina Center of New Jersey, LLC

    Bloomfield, New Jersey, 07003

  • The Eye Associates

    Bradenton, Florida, 34209

  • Pennsylvania Retina Specialists, P.C.

    Camp Hill, Pennsylvania, 17011

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Charlotte Eye Ear Nose & Throat Associates, PA

    Charlotte, North Carolina, 28210

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242-5664

  • Ohio State University

    Columbus, Ohio, 43212

  • DuPage Medical Group

    Downers Grove, Illinois, 60515

  • Midwest Retina, Inc.

    Dublin, Ohio, 43016

  • Kovach Eye Institute

    Elmhurst, Illinois, 60126

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • The University of Texas Medical Branch

    Galveston, Texas, 77550

  • Retinal Consultants of Arizona

    Gilbert, Arizona, 85296

  • Specialty Eye Care Medical Center, Inc.

    Glendale, California, 91203

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina Consultants, P.C.

    Hagerstown, Maryland, 21740

  • Long Island Vitreoretinal Consultants

    Hauppauge, New York, 11788

  • University of California at Irvine Gavin Herbert Eye Institute

    Irvine, California, 92697-4375

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Retina Associates of Orange County

    Laguna Hills, California, 92653

  • Delaware Valley Retina Associates

    Lawrenceville, New Jersey, 08648

  • Sabates Eye Centers

    Leawood, Kansas, 66211

  • South Coast Retina Center

    Long Beach, California, 90807

  • Retina Macula Specialists of Miami

    Miami, Florida, 33126

  • MedEye Associates

    Miami, Florida, 33143

  • Premiere Retina Specialists

    Midland, Texas, 79706

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

  • Maculacare - New York

    New York, New York, 10021

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

  • East Bay Retina Consultants, Inc.

    Oakland, California, 94609

  • San Diego Retina Associates

    Oceanside, California, 92056

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211

  • California Eye Specialist Medical Group

    Pasadena, California, 91107

  • Barnet Dulaney Perkins Eye Center - Phoenix

    Phoenix, Arizona, 85016-4701

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505

  • UC Davis Medical Center, Department of Ophthalmology

    Sacramento, California, 95817

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95841

  • University of Utah, John Moran Eye Center

    Salt Lake City, Utah, 84132

  • Retina Associates of South Texas, PA

    San Antonio, Texas, 78240

  • West Coast Retina Medical Group

    San Francisco, California, 94109

  • Pacific Eye Associates

    San Francisco, California, 94115

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Northwest Arkansas Retina Associates

    Springdale, Arkansas, 72762

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Retina Vitreous Surgeons of Central NY, PC

    Syracuse, New York, 13224

  • Retina Associate of Florida, P.A.

    Tampa, Florida, 33609

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

  • Retina Centers, PC

    Tucson, Arizona, 85704

  • Wagner Macula and Retina Center

    Virginia Beach, Virginia, 23454

  • Wheaton Eye Clinic, Clinical Research Center, LLC

    Wheaton, Illinois, 60187

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

  • Vitreo-Retinal Associates, Pc

    Worcester, Massachusetts, 01605

Other trials in United States

Japan32 sites

  • Hyogo Prefectural Amagasaki Hospital General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • Nihon University Hospital

    Chiyoda City, Tokyo, 101-8309

  • Chofu Eye Clinic

    Chōfu, Tokyo, 182-0024

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Iida Municipal Hospital

    Iida, Nagano, 395-8502

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki, Ibaraki, 300-0395

  • Kameda Clinic

    Kamogawa, Chiba, 296-0041

  • Kikuna Yuda Eye Clinic

    Kanagawa, Kanto, 222-0011

  • Kokura Kinen Hospital

    Kitakyushu, 802-8555

  • Ideta Eye Hospital

    Kumamoto, 860-0027

  • Kimura Eye And Internal Medicine Hospital

    Kure, Hiroshima, 737-0029

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-0851

  • Japan Community Health Care Organization Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Nara Medical University Hospital

    Nara, 634-8522

  • Ogaki Tokushukai Hospital

    Ōgaki, Gifu, 503-0015

  • Medical Corporation Jinshikai Nishi Eye Hospital

    Osaka, 537-0025

  • Musashi Dream Clinic

    Osaka, 543-0027

  • Tane Memorial Eye Hospital

    Osaka, 550-0024

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Sapporo City General Hospital

    Sapporo, Hokkaido, 060-8604

  • Takeuchi Eye Clinic

    Taitō City, Tokyo, 111-0051

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba, 279-0021

  • Otakeganka Tsukimino Clinic

    Yamato, Kanagawa, 242-0001

Other trials in Japan

United Kingdom20 sites

  • Barnet Hospital

    Barnet, EN5 3DJ

  • Bradford Royal Infirmary (BRI)

    Bradford, West Yorkshire, BD18 4JN

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • University Hospital of Wales

    Cardiff, Wales, CF4 4XW

  • ESNEFT Essex County Hospital

    Colchester, Essex, CO4 5JR

  • Royal Derby Hospital

    Derby, Derbyshire, DE22 3NE

  • Frimley Park Hospital

    Frimley, Camberley, GU17 7UJ

  • Royal Surrey Hospital

    Guildford, South East, S10 2TB

  • Royal Liverpool University Hospital

    Liverpool, North West England, L7 8XP

  • University Hospital Aintree

    Liverpool, L9 7AL

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Barnet Royal Free Hospital

    London, EN53DJ

  • King's College Hospital

    London, SE5 9RJ

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP

  • Oxford Eye Hospital, John Radcliffe Hospital

    Oxford, Headington, OX3 9DU

  • Hospital of St. Cross

    Rugby, CV22 5PX

  • Sheffield Teaching Hospitals

    Sheffield, Yorkshire, S10 2TB

  • University Hospital Southampton

    Southampton, Hampshire, SO16 6YD

  • City Hospitals Sunderland NHS

    Sunderland, SR2 9HP

  • Heart of England NHS Foundation Trust, Good Hope Hospital

    Sutton Coldfield, Staffordshire, B75 7RR

Other trials in United Kingdom

Italy13 sites

  • A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9

    Bologna, 40138

  • Ospedale Clinicizzato

    Chieti, Abruzzo, 66100

  • Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale

    Florence, Tuscany, 50134

  • Clinica Oculistica DINOGMI Universita di Genova

    Genova, 16132

  • Eye Clinic - Fondazione IRCCS

    Milan, Lombardy, 20122

  • Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano

    Milan, Lombardy, 20157

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello

    Pisa, Tuscany, 56124

  • Policlinico Agostino Gemelli

    Roma, 00168

  • Fondazione G.B. Bietti-IRCCS

    Roma, 00198

  • Ospedale Molinette

    Turin, Piedmont, 10126

  • Clinica Oculistica, Ospedale Santa Maria della Misericordia

    Udine, Friuli Venezia Giulia, 33100

  • IRCCS - Istuto di Recovero e Cura a Carattere Scientifico

    Verona, Vento, 37024

Other trials in Italy

Hungary9 sites

  • Magyar Honvedseg Egeszegugyi Kozpont

    Budapest, 1068

  • Semmelweis University

    Budapest, 1085

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Szent Imre Teaching Hospital

    Budapest, 1115

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • University of Debrecen, Medical Center

    Debrecen, 4032

  • Ganglion Medical Centre

    Pécs, 7621

  • University of Szeged

    Szeged, 6720

  • Markusovszki Teaching Hospital

    Szombathely, 9700

Other trials in Hungary

Australia6 sites

  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002

  • Specialist Eye Group

    Glen Waverley, Victoria, 3150

  • Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Save Sight Institute, University of Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

Brazil5 sites

  • Instistuto da Visao - Hospital de Olhos Ltda

    Belo Horizonte, Minas Gerais, 30330-000

  • Centro Brasileiro de Cirurgia de Olhos - CBCO

    Goiânia, Goiás, 74210-010

  • Clinica de Olhos Dr. Suel Abujamra

    São Paulo, 01525-001

  • Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)

    São Paulo, 04023-062

  • Hospital Oftalmologico de Sorocaba

    Sorocaba, São Paulo, 18031-060

Other trials in Brazil

Canada5 sites

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • St Joseph's Health Care London - Ivey Eye Institute

    London, Ontario, N6A 4V2

  • Canadian Centre for Advanced Eye Therapeutics Inc

    Mississauga, Ontario, L4W 1W9

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H 8L6

  • Toronto Retina Institute

    Toronto, Ontario, M3C0G9

Other trials in Canada

Poland5 sites

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Klinika Okulistyczna Jasne Blonia

    Lodz, 91-134

  • Centrum Diagnostyki i Mikrochirurgii

    Olsztyn, 10-424

  • Retina Eye Hospital

    Warsaw, 01-364

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50-556

Other trials in Poland

Taiwan5 sites

  • Department of Ophthalmology Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Department of Ophthalmology National Taiwan University Hospital

    Taipei, 100

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111

  • Chang Gung Medical Foundation, Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Netherlands4 sites

  • Academic Medical Center

    Amsterdam, North Holland, 1105 AZ

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • Oogziekenhuis Rotterdam

    Rotterdam, North Holland, 3011 BH

  • Elisabeth Hospital

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

South Africa3 sites

  • Pasteur Medical Centre

    Bloemfontein, 9301

  • Dr Actons Privat Practice

    Cape Town, 7530

  • Pretoria Eye Institute, Private Practice

    Pretoria, 0007

Other trials in South Africa

Denmark2 sites

  • Rigshospitalet-Glostrup

    Glostrup Municipality, Capital Region, 2600

  • Odense University Hospital

    Odense, Region Syddanmark, C 5000

Other trials in Denmark

Russia2 sites

  • Scientific Research Institute of Ocular Diseases of RAMS

    Moscow, 119021

  • S. Fyodorov Eye Microsurgery Federal State Institution

    Moscow, 127486

Other trials in Russia

Turkey (Türkiye)2 sites

  • Ankara Uni Med Fac

    Ankara, 06590

  • Dokuz Eylul Uni Med Fac

    Izmir, 35340

Other trials in Turkey (Türkiye)

Peru1 site

  • Macula D&T Eye Center

    San Isidro, Lima region, 27

Other trials in Peru

About this study

Official title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Being tested
Abicipar Pegol, Ranibizumab, Sham Procedure
Medical subject headings
Macular Degeneration

What participants receive

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

  • Abicipar PegolDrug

    Also called AGN-150998

    Abicipar pegol intravitreal injection.

  • RanibizumabDrug

    Also called Lucentis®

    Ranibizumab intravitreal injection.

  • Sham ProcedureOther

    Sham injection.

Study groups in NCT02462486
Study groupRoleWhat they receive
Abicipar Pegol 2 mg (2Q8)ExperimentalAbicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Receives: Drug: Abicipar Pegol; Other: Sham Procedure
Abicipar Pegol 2 mg (2Q12)ExperimentalAbicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Receives: Drug: Abicipar Pegol; Other: Sham Procedure
Ranibizumab (rQ4)Active comparatorRanibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Receives: Drug: Ranibizumab

What is being measured

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

  1. Percentage of Participants With Stable Vision at Week 52

    Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

    Measured: Baseline to Week 52

Secondary outcomes (4)

  1. Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52

    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

    Measured: Baseline to Week 52

  2. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52

    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.

    Measured: Baseline to Week 52

  3. Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52

    BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

    Measured: Baseline to Week 52

  4. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52

    NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.

    Measured: Baseline to Week 52

Timeline

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

  1. First posted4 Jun 2015 (estimated)
  2. Study start25 Jun 2015
  3. Primary completion12 Apr 2018
  4. Study completion6 Jun 2019

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
949 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462486
Sponsor's protocol ID
150998-006
Other IDs
2014-004580-20, SEQUOIA, 2014
Status last verified
Jul 2020
First submitted
2 Jun 2015
Last updated
30 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abicipar Pegol and Ranibizumab in people with Macular Degeneration, run by Allergan at 187 sites in 16 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, Japan, United Kingdom, Italy, Hungary and 11 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 30 Jul 2020). 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 Stable Vision at Week 52 (time frame: Baseline to Week 52). 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 NCT02462486.

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 30 Jul 2020.

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