Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

NCT03891446 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: 1698-302-0072018-003597-262023-504601-36-00
• Study Type: interventional
• Target: 455
• Locations: 26 countries
• Sites: 124

Brief 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 (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-Angle Glaucoma; Ocular Hypertension; Bimatoprost; DURYSTA

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Lead-in study 192024-091 or -092 or -095

EXPERIMENTAL

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

Lead-in study 192024-093 Stage 1

EXPERIMENTAL

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

Lead-in study 192024-093 Stage 2

EXPERIMENTAL

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.

Drug: Bimatoprost SR; Other: Standard of Care

Lead-in study ARGOS

EXPERIMENTAL

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.

Drug: Bimatoprost SR; Other: Standard of Care

Interventions

Bimatoprost SR DRUG

Intraocular implant

Also known as: DURYSTA

Lead-in study 192024-093 Stage 2; Lead-in study ARGOS

Standard of Care OTHER

Standard of care treatment based on investigator's judgement.

Lead-in study 192024-091 or -092 or -095; Lead-in study 192024-093 Stage 1; Lead-in study 192024-093 Stage 2; Lead-in study ARGOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (124)

Trinity Research Group /ID# 240190

Dothan, Alabama, 36301, United States

Location

Arizona Eye Center - West Ray Road /ID# 240239

Chandler, Arizona, 85224, United States

Location

Arizona Glaucoma Specialists /ID# 240212

Phoenix, Arizona, 85050-4265, United States

Location

M&M Eye Institute /ID# 240236

Prescott, Arizona, 86301, United States

Location

Horizon Eye Specialists & Lasik Centers /ID# 240255

Sun City, Arizona, 85351, United States

Location

Angeles Eye Institute /ID# 250397

Culver City, California, 90232, United States

Location

Duplicate_Lakeside Vision Center /ID# 240204

Irvine, California, 92604, United States

Location

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

La Jolla, California, 92093, United States

Location

The Eye Research Foundation /ID# 240186

Newport Beach, California, 92663-3637, United States

Location

North Bay Eye Associates Inc. /ID# 248912

Petaluma, California, 94954-2387, United States

Location

Duplicate_Martel Eye Medical Group /ID# 240291

Rancho Cordova, California, 95670-2968, United States

Location

The Clinical Trials Network (CTNx) /ID# 240284

Redding, California, 96001, United States

Location

Sacramento Eye Consultants /ID# 240263

Sacramento, California, 95815, United States

Location

Pacific Eye Associates /ID# 240234

San Francisco, California, 94115, United States

Location

Wolstan & Goldberg Eye Associates /ID# 240221

Torrance, California, 90505, United States

Location

Colorado Eye Institute /ID# 248910

Colorado Springs, Colorado, 80924-7003, United States

Location

Specialty Retina Center /ID# 240254

Coral Springs, Florida, 33067, United States

Location

Nature Coast Clinical Research - Crystal River /ID# 240334

Crystal River, Florida, 34429, United States

Location

Bruce Segal, MD /ID# 240292

Delray Beach, Florida, 33484-6540, United States

Location

Eye Associates of Fort Meyers /ID# 240218

Fort Myers, Florida, 33901, United States

Location

Levenson Eye Associates Inc. /ID# 240209

Jacksonville, Florida, 32204, United States

Location

MedEye Associates /ID# 240333

Miami, Florida, 33143, United States

Location

Logan Ophthalmic Research Inc. /ID# 240280

Tamarac, Florida, 33321, United States

Location

International Research Center /ID# 240346

Tampa, Florida, 33603, United States

Location

University of South Florida- Neuroscience Institute /ID# 250980

Tampa, Florida, 33613, United States

Location

Duplicate_Emory University /ID# 240328

Atlanta, Georgia, 30322-1013, United States

Location

Coastal Research Associates /ID# 240192

Roswell, Georgia, 30076, United States

Location

Chicago Eye Specialists /ID# 240270

Bedford Park, Illinois, 60638, United States

Location

University of Illinois at Chicago /ID# 250981

Chicago, Illinois, 60607, United States

Location

Kovach Eye Institute /ID# 250442

Elmhurst, Illinois, 60126-2821, United States

Location

IN Univ School of Medicine /ID# 240294

Indianapolis, Indiana, 46202-2884, United States

Location

The Eye Care Institute /ID# 240289

Louisville, Kentucky, 40206-1738, United States

Location

Duplicate_Tulane University /ID# 240327

New Orleans, Louisiana, 70112-2699, United States

Location

Clinical Eye Research of Boston LLC /ID# 240203

Winchester, Massachusetts, 01890, United States

Location

Fraser Eye Center /ID# 240245

Fraser, Michigan, 48026, United States

Location

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

Chesterfield, Missouri, 63017, United States

Location

Tekwani Vision Center /ID# 240220

St Louis, Missouri, 63128, United States

Location

Eye Associates of North Jersey /ID# 250445

Dover, New Jersey, 07801-1629, United States

Location

Glaucoma Care Center /ID# 250978

Livingston, New Jersey, 07039, United States

Location

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

Newark, New Jersey, 07103-2425, United States

Location

Eye Associates of New Mexico /ID# 240216

Albuquerque, New Mexico, 87109, United States

Location

Ophthalmic Consultants Long Island /ID# 240211

Oceanside, New York, 11572, United States

Location

Rochester Ophthalmological Group PC /ID# 240290

Rochester, New York, 14618-2616, United States

Location

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

Slingerlands, New York, 12159, United States

Location

Montefiore Hospital /ID# 240324

The Bronx, New York, 10467-2404, United States

Location

Asheville Eye Associates /ID# 240202

Asheville, North Carolina, 28803, United States

Location

Charlotte Eye,Ear,Nose Throat /ID# 240339

Belmont, North Carolina, 28012, United States

Location

Albemarle Clinical Trials LLC /ID# 240219

Elizabeth City, North Carolina, 27909, United States

Location

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

Winston-Salem, North Carolina, 27101, United States

Location

Bergstrom Eye Research LLC /ID# 240257

Fargo, North Dakota, 58103, United States

Location

Oklahoma Eye Surgeons /ID# 250430

Oklahoma City, Oklahoma, 73112, United States

Location

Legacy Devers Eye Institute /ID# 240210

Portland, Oregon, 97210, United States

Location

Scott and Christie and Associates /ID# 240189

Cranberry Township, Pennsylvania, 16066, United States

Location

Eye Specialty Group /ID# 240241

Memphis, Tennessee, 38120, United States

Location

Vanderbilt Eye Institute /ID# 252659

Nashville, Tennessee, 37232-0025, United States

Location

Advancing Vision Research /ID# 240288

Smyrna, Tennessee, 37167, United States

Location

Keystone Research LTD /ID# 240185

Austin, Texas, 78731-4203, United States

Location

Houston Eye Associates /ID# 240340

Houston, Texas, 77025, United States

Location

DCT Shah Eye Research Institut /ID# 240306

Mission, Texas, 78572, United States

Location

Plano Office /ID# 240243

Plano, Texas, 75093, United States

Location

San Antonio Eye Center /ID# 240238

San Antonio, Texas, 78215, United States

Location

Eye associates /ID# 240265

San Antonio, Texas, 78229, United States

Location

Medical Center Ophthalmology Associates /ID# 240208

San Antonio, Texas, 78240-1502, United States

Location

Emerson Clinical Research Institute. LLC /ID# 240274

Falls Church, Virginia, 22046, United States

Location

Piedmont Eye Center /ID# 240187

Lynchburg, Virginia, 24502, United States

Location

Vistar Eye Center /ID# 240198

Roanoke, Virginia, 24011, United States

Location

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

CABA, Buenos Aires, 1122, Argentina

Location

Clinica Privada de Ojos /ID# 240272

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Universitario Austral /ID# 240331

Pilar, Buenos Aires, 1629, Argentina

Location

Oftalmología Global /ID# 240244

Rosario, Santa Fe Province, 2000, Argentina

Location

Oftar Mendoza /ID# 240308

Mendoza, 1019, Argentina

Location

Universitair Ziekenhuis Leuven /ID# 240312

Leuven, Vlaams-Brabant, 3000, Belgium

Location

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

Campo Grande, Mato Grosso do Sul, 79002-075, Brazil

Location

Clinica De Oftalmologia Nova Campinas /ID# 240271

Campinas, São Paulo, 13092-108, Brazil

Location

Hospital Oftalmologico Medicina dos Olhos /ID# 240277

Osasco, São Paulo, 0601-8180, Brazil

Location

Hospital Sao Paulo /ID# 240278

São Paulo, 04023-062, Brazil

Location

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

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Ophthalmic Consultant Centres /ID# 240205

Mississauga, Ontario, L4W 1W9, Canada

Location

Clinica de Oftalmologia Sandiego /ID# 240233

Medellín, Antioquia, 050016, Colombia

Location

Fundacion Oftalmologica Nacional /ID# 240226

Bogotá, Bogota D.C., 110231, Colombia

Location

Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

Bucaramanga, Santander Department, 681004, Colombia

Location

Ocni klinika Pardubice /ID# 240347

Pardubice, 530 02, Czechia

Location

Rigshospitalet Glostrup /ID# 240330

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Bostan Diagnostic Eye Center /ID# 240268

Cairo, Egypt

Location

Duplicate_Ain Shams University Hospital /ID# 240338

Cairo, Egypt

Location

CHU Bordeaux - Hopital Pellegrin /ID# 240316

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Centre Ophtalmologique Pôle Vision /ID# 240256

Écully, Rhone, 69130, France

Location

Internationale Innovative Ophthalmochirurgie /ID# 240232

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

Universitaetsklinikum Magdeburg /ID# 240314

Magdeburg, 39120, Germany

Location

The Chinese University of Hong Kong /ID# 240283

Hong Kong, Hong Kong

Location

Galilee Medical Center /ID# 251967

Nahariya, Northern District, 2210001, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 240311

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 240332

Haifa, 3109601, Israel

Location

Bnai Zion Medical Center /ID# 240297

Haifa, 3339419, Israel

Location

The Lady Davis Carmel Medical Center /ID# 240293

Haifa, 34362, Israel

Location

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

Catania, 95123, Italy

Location

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

Chieti, 67100, Italy

Location

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

Perugia, 06156, Italy

Location

Azienda Ospedaliero Universitaria Pisana /ID# 240301

Pisa, 56126, Italy

Location

Capital Eye Specialists /ID# 240259

Wellington, 6011, New Zealand

Location

Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

Lima, LIMA 27, Peru

Location

Asian Eye Institute /ID# 240213

Makati City, 1200, Philippines

Location

Asian Eye Institute /ID# 240214

Makati City, 1200, Philippines

Location

Peregrine Eye and Laser Institute /ID# 240260

Makati City, 1209, Philippines

Location

Oftalmika sp. z o.o. /ID# 240201

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631, Poland

Location

Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

Lublin, Lublin Voivodeship, 20-079, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-809, Poland

Location

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

Olsztyn, Warmian-Masurian Voivodeship, 10-424, Poland

Location

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

Novosibirsk, Novosibirsk Oblast, 630071, Russia

Location

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

Omsk, Omsk Oblast, 644024, Russia

Location

Singapore National Eye Centre /ID# 240224

Singapore, 168251, Singapore

Location

Pretoria Eye Institute - Private Practice /ID# 240223

Pretoria, Gauteng, 0083, South Africa

Location

Asan Medical Center /ID# 240286

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 240335

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Duplicate_Seoul National University Hospital /ID# 240262

Seoul, 03080, South Korea

Location

Hospital Universitario Reina Sofia /ID# 240322

Córdoba, Cordoba, 14004, Spain

Location

Hospital Clinico San Carlos /ID# 240303

Madrid, 28040, Spain

Location

Hospital Universitario Virgen Macarena /ID# 240325

Seville, 41009, Spain

Location

Maharaj Nakorn Chiang Mai Hospital /ID# 240194

Chiang Mai, 50200, Thailand

Location

Thammasat University Hospital /ID# 240231

Pathum Thani, 12120, Thailand

Location

Eskisehir Osmangazi University Medical School /ID# 240225

Eskişehir, 26480, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

Istanbul, 34899, Turkey (Türkiye)

Location

Addenbrookes Hospital /ID# 240351

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Duplicate_NHS Lothian /ID# 240318

Edinburgh, EH3 9HE, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 27, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DE (2); KR (3); ES (3); TH (2); TU (2); SG (1); PH (3); BE (1); RU (2); NZ (1); EG (2); HK (1); PE (1); GB (2); CA (2); US (66); IT (4); PL (4); CZ (1); FR (2); BR (4); AR (5); IL (5); CO (3); DK (1); ZA (1)