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

February 9, 2024 updated by: AbbVie

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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Rosario, Santa Fe, Argentina, 2000
        • Oftalmología Global /ID# 240244
  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 240312
  • Brazil
      • Campo Grande, Brazil, 79002-075
        • Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
      • Sao Paulo, Brazil, 04023-062
        • Hospital Sao Paulo /ID# 240278
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13092-108
        • Clinica De Oftalmologia Nova Campinas /ID# 240271
      • Osasco, Sao Paulo, Brazil, 0601-8180
        • Hospital Oftalmologico Medicina dos Olhos /ID# 240277
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Dalhousie University /ID# 240336
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1W9
        • Ophthalmic Consultant Centres /ID# 240205
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050016
        • Clinica de Oftalmologia Sandiego /ID# 240233
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110231
        • Fundacion Oftalmologica Nacional /ID# 240226
    • Santander
      • Bucaramanga, Santander, Colombia, 681004
        • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
  • Czechia
      • Pardubice, Czechia, 530 02
        • Ocni klinika Pardubice /ID# 240347
  • Denmark
    • Hovedstaden
      • Glostrup, Hovedstaden, Denmark, 2600
        • Rigshospitalet Glostrup /ID# 240330
  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital /ID# 240338
      • Cairo, Egypt
        • Bostan Diagnostic Eye Center /ID# 240268
  • France
      • Ecully, France, 69130
        • Centre Ophtalmologique Pôle Vision /ID# 240256
    • Gironde
      • Bordeaux CEDEX, Gironde, France, 33076
        • CHU Bordeaux - Hopital Pellegrin /ID# 240316
  • Germany
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg /ID# 240314
    • Nordrhein-Westfalen
      • Dusseldorf, Nordrhein-Westfalen, Germany, 40212
        • Internationale Innovative Ophthalmochirurgie /ID# 240232
  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong /ID# 240283
  • Israel
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Rambam Health Care Campus /ID# 240332
      • Haifa, H_efa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 240297
      • Haifa, H_efa, Israel, 34362
        • The Lady Davis Carmel Medical Center /ID# 240293
    • HaTsafon
      • Naharia, HaTsafon, 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
        • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305
      • Chieti, Italy, 66100
        • Azienda Sanitaria Locale (ASL) Chieti /ID# 240217
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 240301
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Azienda Ospedaliera di Perugia /ID# 240310
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 240262
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 240286
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 240335
  • 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
      • Bydgoszcz, Poland, 85-631
        • OFTALMIKA Sp. z o.o. /ID# 240201
      • Lublin, Poland, 20-079
        • Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-809
        • Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307
  • Russian Federation
      • Novosibirsk, Russian Federation, 630071
        • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
      • Omsk, Russian Federation, 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
  • Spain
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 240322
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos /ID# 240303
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 240325
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital /ID# 240194
      • Pathumthani, Thailand, 12120
        • Thammasat University Hospital /ID# 240231
  • Turkey
      • Eskisehir, Turkey, 26480
        • Eskisehir Osmangazi University Medical School /ID# 240225
      • Istanbul, Turkey, 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust /ID# 240351
      • Edinburgh, United Kingdom, EH3 9HE
        • Duplicate_NHS Lothian /ID# 240318
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Trinity Research Group /ID# 240190
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Eye Center /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
        • Walman Eye Center /ID# 240255
    • California
      • Culver City, California, United States, 90232
        • Angeles Eye Institute /ID# 250397
      • Irvine, California, United States, 92604
        • 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
        • 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, 33612
        • University of South Florida /ID# 250980
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • 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
        • 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
      • Saint 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
      • Bronx, New York, United States, 10467-2404
        • Montefiore Hospital /ID# 240324
      • 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
    • 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
        • James D Branch MD /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
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Approximately 24 months
Retreatment or rescue administered for IOP lowering, determined by the investigator.
Approximately 24 months
Number of patients experiencing a treatment emergent adverse event
Time Frame: Approximately 24 months
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

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Estimated)

August 7, 2026

Study Completion (Estimated)

August 7, 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)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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