Long-term Safety and Efficacy Extension Trial of Bimatoprost SR (MAIA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Other: Standard of Care; Drug: Bimatoprost SR

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina, 1019
    • Oftar Mendoza /ID# 240308
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1122
      • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Clinica Privada de Ojos /ID# 240272
    • Pilar, Buenos Aires, Argentina, 1629
      • Hospital Universitario Austral /ID# 240331
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Oftalmología Global /ID# 240244
• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 240312
• Brazil
  • São Paulo, Brazil, 04023-062
    • Hospital Sao Paulo /ID# 240278
  • Mato Grosso do Sul
    • Campo Grande, Mato Grosso do Sul, Brazil, 79002-075
      • Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
  • São Paulo
    • Campinas, São Paulo, Brazil, 13092-108
      • Clinica De Oftalmologia Nova Campinas /ID# 240271
    • Osasco, São Paulo, Brazil, 0601-8180
      • Hospital Oftalmologico Medicina dos Olhos /ID# 240277
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1W9
      • Ophthalmic Consultant Centres /ID# 240205
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050016
      • Clinica de Oftalmologia Sandiego /ID# 240233
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110231
      • Fundacion Oftalmologica Nacional /ID# 240226
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 681004
      • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
• Czechia
  • Pardubice, Czechia, 530 02
    • Ocni klinika Pardubice /ID# 240347
• Denmark
  • Capital Region
    • Glostrup Municipality, Capital Region, Denmark, 2600
      • Rigshospitalet Glostrup /ID# 240330
• Egypt
  • Cairo, Egypt
    • Bostan Diagnostic Eye Center /ID# 240268
  • Cairo, Egypt
    • Duplicate_Ain Shams University Hospital /ID# 240338
• France
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33076
      • CHU Bordeaux - Hopital Pellegrin /ID# 240316
  • Rhone
    • Écully, Rhone, France, 69130
      • Centre Ophtalmologique Pôle Vision /ID# 240256
• Germany
  • Magdeburg, Germany, 39120
    • Universitaetsklinikum Magdeburg /ID# 240314
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40212
      • Internationale Innovative Ophthalmochirurgie /ID# 240232
• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong /ID# 240283
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 240332
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center /ID# 240297
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center /ID# 240293
  • Northern District
    • Nahariya, Northern District, Israel, 2210001
      • Galilee Medical Center /ID# 251967
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 240311
• Italy
  • Catania, Italy, 95123
    • AOU Policlinico G. Rodolico - San Marco /ID# 240305
  • Chieti, Italy, 67100
    • ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana /ID# 240301
• New Zealand
  • Wellington, New Zealand, 6011
    • Capital Eye Specialists /ID# 240259
• Peru
  • Lima, Peru, LIMA 27
    • Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
• Philippines
  • Makati City, Philippines, 1200
    • Asian Eye Institute /ID# 240213
  • Makati City, Philippines, 1200
    • Asian Eye Institute /ID# 240214
  • Makati City, Philippines, 1209
    • Peregrine Eye and Laser Institute /ID# 240260
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-631
      • Oftalmika sp. z o.o. /ID# 240201
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-079
      • Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-809
      • Duplicate_Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307
  • Warmian-Masurian Voivodeship
    • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-424
      • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248
• Russia
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russia, 630071
      • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644024
      • Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
• Singapore
  • Singapore, Singapore, 168251
    • Singapore National Eye Centre /ID# 240224
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0083
      • Pretoria Eye Institute - Private Practice /ID# 240223
• South Korea
  • Seoul, South Korea, 03080
    • Duplicate_Seoul National University Hospital /ID# 240262
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 240286
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 240335
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos /ID# 240303
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 240325
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia /ID# 240322
• Thailand
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital /ID# 240194
  • Pathum Thani, Thailand, 12120
    • Thammasat University Hospital /ID# 240231
• Turkey (Türkiye)
  • Eskişehir, Turkey (Türkiye), 26480
    • Eskisehir Osmangazi University Medical School /ID# 240225
  • Istanbul, Turkey (Türkiye), 34899
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
• United Kingdom
  • Edinburgh, United Kingdom, EH3 9HE
    • Duplicate_NHS Lothian /ID# 240318
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrookes Hospital /ID# 240351
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group /ID# 240190
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center - West Ray Road /ID# 240239
    • Phoenix, Arizona, United States, 85050-4265
      • Arizona Glaucoma Specialists /ID# 240212
    • Prescott, Arizona, United States, 86301
      • M&M Eye Institute /ID# 240236
    • Sun City, Arizona, United States, 85351
      • Horizon Eye Specialists & Lasik Centers /ID# 240255
  • California
    • Culver City, California, United States, 90232
      • Angeles Eye Institute /ID# 250397
    • Irvine, California, United States, 92604
      • Duplicate_Lakeside Vision Center /ID# 240204
    • La Jolla, California, United States, 92093
      • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 240186
    • Petaluma, California, United States, 94954-2387
      • North Bay Eye Associates Inc. /ID# 248912
    • Rancho Cordova, California, United States, 95670-2968
      • Duplicate_Martel Eye Medical Group /ID# 240291
    • Redding, California, United States, 96001
      • The Clinical Trials Network (CTNx) /ID# 240284
    • Sacramento, California, United States, 95815
      • Sacramento Eye Consultants /ID# 240263
    • San Francisco, California, United States, 94115
      • Pacific Eye Associates /ID# 240234
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates /ID# 240221
  • Colorado
    • Colorado Springs, Colorado, United States, 80924-7003
      • Colorado Eye Institute /ID# 248910
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Specialty Retina Center /ID# 240254
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research - Crystal River /ID# 240334
    • Delray Beach, Florida, United States, 33484-6540
      • Bruce Segal, MD /ID# 240292
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Meyers /ID# 240218
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates Inc. /ID# 240209
    • Miami, Florida, United States, 33143
      • MedEye Associates /ID# 240333
    • Tamarac, Florida, United States, 33321
      • Logan Ophthalmic Research Inc. /ID# 240280
    • Tampa, Florida, United States, 33603
      • International Research Center /ID# 240346
    • Tampa, Florida, United States, 33613
      • University of South Florida- Neuroscience Institute /ID# 250980
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Duplicate_Emory University /ID# 240328
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates /ID# 240192
  • Illinois
    • Bedford Park, Illinois, United States, 60638
      • Chicago Eye Specialists /ID# 240270
    • Chicago, Illinois, United States, 60607
      • University of Illinois at Chicago /ID# 250981
    • Elmhurst, Illinois, United States, 60126-2821
      • Kovach Eye Institute /ID# 250442
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • IN Univ School of Medicine /ID# 240294
  • Kentucky
    • Louisville, Kentucky, United States, 40206-1738
      • The Eye Care Institute /ID# 240289
  • Louisiana
    • New Orleans, Louisiana, United States, 70112-2699
      • Duplicate_Tulane University /ID# 240327
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston LLC /ID# 240203
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Center /ID# 240245
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
    • St Louis, Missouri, United States, 63128
      • Tekwani Vision Center /ID# 240220
  • New Jersey
    • Dover, New Jersey, United States, 07801-1629
      • Eye Associates of North Jersey /ID# 250445
    • Livingston, New Jersey, United States, 07039
      • Glaucoma Care Center /ID# 250978
    • Newark, New Jersey, United States, 07103-2425
      • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico /ID# 240216
  • New York
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants Long Island /ID# 240211
    • Rochester, New York, United States, 14618-2616
      • Rochester Ophthalmological Group PC /ID# 240290
    • Slingerlands, New York, United States, 12159
      • Glaucoma associates/consultants of the capital region /ID# 240195
    • The Bronx, New York, United States, 10467-2404
      • Montefiore Hospital /ID# 240324
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates /ID# 240202
    • Belmont, North Carolina, United States, 28012
      • Charlotte Eye,Ear,Nose Throat /ID# 240339
    • Elizabeth City, North Carolina, United States, 27909
      • Albemarle Clinical Trials LLC /ID# 240219
    • Winston-Salem, North Carolina, United States, 27101
      • Private Practice - Dr. James D. Branch /ID# 240188
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research LLC /ID# 240257
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma Eye Surgeons /ID# 250430
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Devers Eye Institute /ID# 240210
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott and Christie and Associates /ID# 240189
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Eye Specialty Group /ID# 240241
    • Nashville, Tennessee, United States, 37232-0025
      • Vanderbilt Eye Institute /ID# 252659
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research /ID# 240288
  • Texas
    • Austin, Texas, United States, 78731-4203
      • Keystone Research LTD /ID# 240185
    • Houston, Texas, United States, 77025
      • Houston Eye Associates /ID# 240340
    • Mission, Texas, United States, 78572
      • DCT Shah Eye Research Institut /ID# 240306
    • Plano, Texas, United States, 75093
      • Plano Office /ID# 240243
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center /ID# 240238
    • San Antonio, Texas, United States, 78229
      • Eye associates /ID# 240265
    • San Antonio, Texas, United States, 78240-1502
      • Medical Center Ophthalmology Associates /ID# 240208
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute. LLC /ID# 240274
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center /ID# 240187
    • Roanoke, Virginia, United States, 24011
      • Vistar Eye Center /ID# 240198

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lead-in study 192024-091 or -092 or -095; 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.	Other: Standard of Care; Standard of care treatment based on investigator's judgement.
Experimental: Lead-in study 192024-093 Stage 1; Participants 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.	Other: Standard of Care; Standard of care treatment based on investigator's judgement.
Experimental: Lead-in study 192024-093 Stage 2; Participants 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.	Other: Standard of Care; Standard of care treatment based on investigator's judgement.; Drug: Bimatoprost SR; Intraocular implant; Other Names: DURYSTA
Experimental: Lead-in study ARGOS; Study 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.	Other: Standard of Care; Standard of care treatment based on investigator's judgement.; Drug: Bimatoprost SR; Intraocular implant; Other Names: DURYSTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of effect of Bimatoprost SR	Retreatment or rescue administered for IOP lowering, determined by the investigator.	Approximately 24 months
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.	Approximately 24 months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Open-Angle Glaucoma; Bimatoprost; DURYSTA
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 1698-302-007; 2018-003597-26 (EudraCT Number); 2023-504601-36-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No