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Open-Angle GlaucomaPhase 3MAIANCT03891446

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

A Phase 3 study testing Bimatoprost SR in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 124 sites in 26 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 study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open-Angle Glaucoma, Ocular Hypertension
What is being tested?
Bimatoprost SR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
455 participants
Where
124 sitesin 26 countries
Study dates
27 Mar 2019to 19 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
  • Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Who cannot join

  • Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
  • Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
  • Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
  • Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
  • For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Trial locations and contacts

124 sites in 26 countries.

124 sites in 26 countries

United States66 sites

  • Eye Associates of New Mexico /ID# 240216

    Albuquerque, New Mexico, 87109

  • Asheville Eye Associates /ID# 240202

    Asheville, North Carolina, 28803

  • Duplicate_Emory University /ID# 240328

    Atlanta, Georgia, 30322-1013

  • Keystone Research LTD /ID# 240185

    Austin, Texas, 78731-4203

  • Chicago Eye Specialists /ID# 240270

    Bedford Park, Illinois, 60638

  • Arizona Eye Center - West Ray Road /ID# 240239

    Chandler, Arizona, 85224

  • Charlotte Eye Ear Nose And Throat Associates- Southpark /ID# 240339

    Charlotte, North Carolina, 28210

  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402

    Chesterfield, Missouri, 63017

  • University of Illinois Hospital and Health Sciences System /ID# 250981

    Chicago, Illinois, 60607

  • Colorado Eye Institute /ID# 248910

    Colorado Springs, Colorado, 80924-7003

  • Specialty Retina Center /ID# 240254

    Coral Springs, Florida, 33067

  • Scott and Christie and Associates /ID# 240189

    Cranberry Township, Pennsylvania, 16066

  • Nature Coast Clinical Research - Crystal River /ID# 240334

    Crystal River, Florida, 34429

  • Angeles Eye Institute /ID# 250397

    Culver City, California, 90232

  • Bruce Segal, MD /ID# 240292

    Delray Beach, Florida, 33484-6540

  • Trinity Research Group /ID# 240190

    Dothan, Alabama, 36301

  • Eye Associates of North Jersey /ID# 250445

    Dover, New Jersey, 07801-1629

  • Albemarle Clinical Trials LLC /ID# 240219

    Elizabeth City, North Carolina, 27909

  • Kovach Eye Institute /ID# 250442

    Elmhurst, Illinois, 60126-2821

  • Emerson Clinical Research Institute - Falls Church /ID# 240274

    Falls Church, Virginia, 22046

  • Bergstrom Eye Research LLC /ID# 240257

    Fargo, North Dakota, 58103

  • Eye Associates of Fort Meyers /ID# 240218

    Fort Myers, Florida, 33901

  • Fraser Eye Center /ID# 240245

    Fraser, Michigan, 48026

  • Houston Eye Associates /ID# 240340

    Houston, Texas, 77025

  • IN Univ School of Medicine /ID# 240294

    Indianapolis, Indiana, 46202-2884

  • Duplicate_Lakeside Vision Center /ID# 240204

    Irvine, California, 92604

  • Levenson Eye Associates- Riverside Park Place /ID# 240209

    Jacksonville, Florida, 32204

  • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

    La Jolla, California, 92093

  • Glaucoma Care Center /ID# 250978

    Livingston, New Jersey, 07039

  • The Eye Care Institute /ID# 240289

    Louisville, Kentucky, 40206-1738

  • Piedmont Eye Center /ID# 240187

    Lynchburg, Virginia, 24502

  • Eye Specialty Group /ID# 240241

    Memphis, Tennessee, 38120

  • MedEye Associates /ID# 240333

    Miami, Florida, 33143

  • DCT Shah Eye Research Institut /ID# 240306

    Mission, Texas, 78572

  • Vanderbilt Eye Institute /ID# 252659

    Nashville, Tennessee, 37232-0025

  • Duplicate_Tulane University /ID# 240327

    New Orleans, Louisiana, 70112-2699

  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181

    Newark, New Jersey, 07103-2425

  • The Eye Research Foundation /ID# 240186

    Newport Beach, California, 92663-3637

  • Ophthalmic Consultants Long Island /ID# 240211

    Oceanside, New York, 11572

  • Oklahoma Eye Surgeons /ID# 250430

    Oklahoma City, Oklahoma, 73112

  • North Bay Eye Associates Inc. /ID# 248912

    Petaluma, California, 94954-2387

  • Arizona Glaucoma Specialists /ID# 240212

    Phoenix, Arizona, 85050-4265

  • Plano Office /ID# 240243

    Plano, Texas, 75093

  • Legacy Devers Eye Institute /ID# 240210

    Portland, Oregon, 97210

  • M&M Eye Institute /ID# 240236

    Prescott, Arizona, 86301

  • Duplicate_Martel Eye Medical Group /ID# 240291

    Rancho Cordova, California, 95670-2968

  • The Clinical Trials Network (CTNx) /ID# 240284

    Redding, California, 96001

  • Vistar Eye Center /ID# 240198

    Roanoke, Virginia, 24011

  • Rochester Ophthalmological Group PC /ID# 240290

    Rochester, New York, 14618-2616

  • Coastal Research Associates /ID# 240192

    Roswell, Georgia, 30076

  • Sacramento Eye Consultants /ID# 240263

    Sacramento, California, 95815

  • San Antonio Eye Center /ID# 240238

    San Antonio, Texas, 78215

  • Eye associates /ID# 240265

    San Antonio, Texas, 78229

  • Medical Center Ophthalmology Associates /ID# 240208

    San Antonio, Texas, 78240-1502

  • Pacific Eye Associates /ID# 240234

    San Francisco, California, 94115

  • Glaucoma associates/consultants of the capital region /ID# 240195

    Slingerlands, New York, 12159

  • Advancing Vision Research /ID# 240288

    Smyrna, Tennessee, 37167

  • Tekwani Vision Center /ID# 240220

    St Louis, Missouri, 63128

  • Horizon Eye Specialists & Lasik Centers /ID# 240255

    Sun City, Arizona, 85351

  • Logan Ophthalmic Research Inc. /ID# 240280

    Tamarac, Florida, 33321

  • International Research Center /ID# 240346

    Tampa, Florida, 33603

  • University of South Florida- Neuroscience Institute /ID# 250980

    Tampa, Florida, 33613

  • Montefiore Hospital /ID# 240324

    The Bronx, New York, 10467-2404

  • Wolstan & Goldberg Eye Associates /ID# 240221

    Torrance, California, 90505

  • Clinical Eye Research of Boston LLC /ID# 240203

    Winchester, Massachusetts, 01890

  • Private Practice - Dr. James D. Branch /ID# 240188

    Winston-Salem, North Carolina, 27101

Other trials in United States

Argentina5 sites

  • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

    CABA, Buenos Aires, 1122

  • Clinica Privada de Ojos /ID# 240272

    Mar del Plata, Buenos Aires, 7600

  • Oftar Mendoza /ID# 240308

    Mendoza, 1019

  • Hospital Universitario Austral /ID# 240331

    Pilar, Buenos Aires, 1629

  • Oftalmología Global /ID# 240244

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Israel5 sites

  • Rambam Health Care Campus /ID# 240332

    Haifa, 3109601

  • Bnai Zion Medical Center /ID# 240297

    Haifa, 3339419

  • The Lady Davis Carmel Medical Center /ID# 240293

    Haifa, 34362

  • Galilee Medical Center /ID# 251967

    Nahariya, Northern District, 2210001

  • Tel Aviv Sourasky Medical Center /ID# 240311

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Brazil4 sites

  • Clinica De Oftalmologia Nova Campinas /ID# 240271

    Campinas, São Paulo, 13092-108

  • Hospital de Olhos de Mato Grosso Do Sul /ID# 240276

    Campo Grande, Mato Grosso do Sul, 79002-075

  • Hospital Oftalmologico Medicina dos Olhos /ID# 240277

    Osasco, São Paulo, 0601-8180

  • Hospital Sao Paulo /ID# 240278

    São Paulo, 04023-062

Other trials in Brazil

Italy4 sites

  • AOU Policlinico G. Rodolico - San Marco /ID# 240305

    Catania, 95123

  • ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217

    Chieti, 67100

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310

    Perugia, 06156

  • Azienda Ospedaliero Universitaria Pisana /ID# 240301

    Pisa, 56126

Other trials in Italy

Poland4 sites

  • Oftalmika sp. z o.o. /ID# 240201

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631

  • Duplicate_Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307

    Gdansk, Pomeranian Voivodeship, 80-809

  • Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

    Lublin, Lublin Voivodeship, 20-079

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248

    Olsztyn, Warmian-Masurian Voivodeship, 10-424

Other trials in Poland

Colombia3 sites

  • Fundacion Oftalmologica Nacional /ID# 240226

    Bogotá, Bogota D.C., 110231

  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

    Bucaramanga, Santander Department, 681004

  • Clinica de Oftalmologia Sandiego /ID# 240233

    Medellín, Antioquia, 050016

Other trials in Colombia

Philippines3 sites

  • Asian Eye Institute /ID# 240213

    Makati City, 1200

  • Asian Eye Institute /ID# 240214

    Makati City, 1200

  • Peregrine Eye and Laser Institute /ID# 240260

    Makati City, 1209

Other trials in Philippines

South Korea3 sites

  • Asan Medical Center /ID# 240286

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 240335

    Seoul, Seoul Teugbyeolsi, 06351

  • Duplicate_Seoul National University Hospital /ID# 240262

    Seoul, 03080

Other trials in South Korea

Spain3 sites

  • Hospital Universitario Reina Sofia /ID# 240322

    Córdoba, 14004

  • Hospital Clinico San Carlos /ID# 240303

    Madrid, 28040

  • Hospital Universitario Virgen Macarena /ID# 240325

    Seville, 41009

Other trials in Spain

Canada2 sites

  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336

    Halifax, Nova Scotia, B3H 2Y9

  • Ophthalmic Consultant Centres /ID# 240205

    Mississauga, Ontario, L4W 1W9

Other trials in Canada

Egypt2 sites

  • Bostan Diagnostic Eye Center /ID# 240268

    Cairo

  • Duplicate_Ain Shams University Hospital /ID# 240338

    Cairo

Other trials in Egypt

France2 sites

  • CHU Bordeaux - Hopital Pellegrin /ID# 240316

    Bordeaux, New Aquitaine, 33076

  • Centre Ophtalmologique Pôle Vision /ID# 240256

    Écully, Rhone, 69130

Other trials in France

Germany2 sites

  • Internationale Innovative Ophthalmochirurgie /ID# 240232

    Düsseldorf, North Rhine-Westphalia, 40212

  • Universitaetsklinikum Magdeburg /ID# 240314

    Magdeburg, 39120

Other trials in Germany

Russia2 sites

  • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251

    Novosibirsk, Novosibirsk Oblast, 630071

  • Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253

    Omsk, Omsk Oblast, 644024

Other trials in Russia

Thailand2 sites

  • Maharaj Nakorn Chiang Mai Hospital /ID# 240194

    Chiang Mai, 50200

  • Thammasat University Hospital /ID# 240231

    Pathum Thani, 12120

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Eskisehir Osmangazi University Medical School /ID# 240225

    Eskişehir, 26480

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

    Istanbul, 34899

Other trials in Turkey (Türkiye)

United Kingdom2 sites

  • Addenbrookes Hospital /ID# 240351

    Cambridge, Cambridgeshire, CB2 2QQ

  • Duplicate_NHS Lothian /ID# 240318

    Edinburgh, EH3 9HE

Other trials in United Kingdom

Belgium1 site

  • Universitair Ziekenhuis Leuven /ID# 240312

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Czechia1 site

  • Ocni klinika Pardubice /ID# 240347

    Pardubice, 530 02

Other trials in Czechia

Denmark1 site

  • Rigshospitalet Glostrup /ID# 240330

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

Hong Kong1 site

  • The Chinese University of Hong Kong /ID# 240283

    Hong Kong

Other trials in Hong Kong

New Zealand1 site

  • Capital Eye Specialists /ID# 240259

    Wellington, 6011

Other trials in New Zealand

Peru1 site

  • Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

    Lima, LIMA 27

Other trials in Peru

Singapore1 site

  • Singapore National Eye Centre /ID# 240224

    Singapore, 168251

Other trials in Singapore

South Africa1 site

  • Pretoria Eye Institute - Private Practice /ID# 240223

    Pretoria, Gauteng, 0083

Other trials in South Africa

About this study

Official title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Being tested
Bimatoprost SR, Standard of Care
Keywords
Open-Angle Glaucoma, Ocular Hypertension, Bimatoprost, DURYSTA
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

  • Bimatoprost SRDrug

    Also called DURYSTA

    Intraocular implant

  • Standard of CareOther

    Standard of care treatment based on investigator's judgement.

Study groups in NCT03891446
Study groupRoleWhat they receive
Lead-in study 192024-091 or -092 or -095ExperimentalStudy eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Receives: Other: Standard of Care
Lead-in study 192024-093 Stage 1ExperimentalParticipants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Receives: Other: Standard of Care
Lead-in study 192024-093 Stage 2ExperimentalParticipants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Receives: Drug: Bimatoprost SR; Other: Standard of Care
Lead-in study ARGOSExperimentalStudy eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Receives: Drug: Bimatoprost SR; Other: Standard of Care

What is being measured

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

  1. Duration of effect of Bimatoprost SR

    Retreatment or rescue administered for IOP lowering, determined by the investigator.

    Measured: Approximately 24 months

  2. Number of patients experiencing a treatment emergent adverse event

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

    Measured: Approximately 24 months

Timeline

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

  1. First posted27 Mar 2019
  2. Study start27 Mar 2019
  3. Primary completion19 Jun 2026
  4. Study completion19 Jun 2026

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
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891446
Sponsor's protocol ID
1698-302-007
Other IDs
2018-003597-26, 2023-504601-36-00, 2023, 2018
Acronym
MAIA
Status last verified
Jul 2026
First submitted
25 Mar 2019
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost SR in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 124 sites in 26 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 5 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Argentina, Israel, Brazil, Italy and 21 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Duration of effect of Bimatoprost SR (time frame: Approximately 24 months). The study lists 2 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 NCT03891446.

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 15 Jul 2026.

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