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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003597-26 | EudraCT Number | ||
| 2023-504601-36-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost SR | Drug | Intraocular implant |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group /ID# 240190 | Dothan | Alabama | 36301 | United States | ||
| Arizona Eye Center - West Ray Road /ID# 240239 |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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|
| Standard of Care | Other | Standard of care treatment based on investigator's judgement. |
|
| Chandler |
| Arizona |
| 85224 |
| United States |
| Arizona Glaucoma Specialists /ID# 240212 | Phoenix | Arizona | 85050-4265 | United States |
| M&M Eye Institute /ID# 240236 | Prescott | Arizona | 86301 | United States |
| Horizon Eye Specialists & Lasik Centers /ID# 240255 | Sun City | Arizona | 85351 | United States |
| Angeles Eye Institute /ID# 250397 | Culver City | California | 90232 | United States |
| Duplicate_Lakeside Vision Center /ID# 240204 | Irvine | California | 92604 | United States |
| Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196 | La Jolla | California | 92093 | United States |
| The Eye Research Foundation /ID# 240186 | Newport Beach | California | 92663-3637 | United States |
| North Bay Eye Associates Inc. /ID# 248912 | Petaluma | California | 94954-2387 | United States |
| Duplicate_Martel Eye Medical Group /ID# 240291 | Rancho Cordova | California | 95670-2968 | United States |
| The Clinical Trials Network (CTNx) /ID# 240284 | Redding | California | 96001 | United States |
| Sacramento Eye Consultants /ID# 240263 | Sacramento | California | 95815 | United States |
| Pacific Eye Associates /ID# 240234 | San Francisco | California | 94115 | United States |
| Wolstan & Goldberg Eye Associates /ID# 240221 | Torrance | California | 90505 | United States |
| Colorado Eye Institute /ID# 248910 | Colorado Springs | Colorado | 80924-7003 | United States |
| Specialty Retina Center /ID# 240254 | Coral Springs | Florida | 33067 | United States |
| Nature Coast Clinical Research - Crystal River /ID# 240334 | Crystal River | Florida | 34429 | United States |
| Bruce Segal, MD /ID# 240292 | Delray Beach | Florida | 33484-6540 | United States |
| Eye Associates of Fort Meyers /ID# 240218 | Fort Myers | Florida | 33901 | United States |
| Levenson Eye Associates Inc. /ID# 240209 | Jacksonville | Florida | 32204 | United States |
| MedEye Associates /ID# 240333 | Miami | Florida | 33143 | United States |
| Logan Ophthalmic Research Inc. /ID# 240280 | Tamarac | Florida | 33321 | United States |
| International Research Center /ID# 240346 | Tampa | Florida | 33603 | United States |
| University of South Florida- Neuroscience Institute /ID# 250980 | Tampa | Florida | 33613 | United States |
| Duplicate_Emory University /ID# 240328 | Atlanta | Georgia | 30322-1013 | United States |
| Coastal Research Associates /ID# 240192 | Roswell | Georgia | 30076 | United States |
| Chicago Eye Specialists /ID# 240270 | Bedford Park | Illinois | 60638 | United States |
| University of Illinois at Chicago /ID# 250981 | Chicago | Illinois | 60607 | United States |
| Kovach Eye Institute /ID# 250442 | Elmhurst | Illinois | 60126-2821 | United States |
| IN Univ School of Medicine /ID# 240294 | Indianapolis | Indiana | 46202-2884 | United States |
| The Eye Care Institute /ID# 240289 | Louisville | Kentucky | 40206-1738 | United States |
| Duplicate_Tulane University /ID# 240327 | New Orleans | Louisiana | 70112-2699 | United States |
| Clinical Eye Research of Boston LLC /ID# 240203 | Winchester | Massachusetts | 01890 | United States |
| Fraser Eye Center /ID# 240245 | Fraser | Michigan | 48026 | United States |
| Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402 | Chesterfield | Missouri | 63017 | United States |
| Tekwani Vision Center /ID# 240220 | St Louis | Missouri | 63128 | United States |
| Eye Associates of North Jersey /ID# 250445 | Dover | New Jersey | 07801-1629 | United States |
| Glaucoma Care Center /ID# 250978 | Livingston | New Jersey | 07039 | United States |
| Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181 | Newark | New Jersey | 07103-2425 | United States |
| Eye Associates of New Mexico /ID# 240216 | Albuquerque | New Mexico | 87109 | United States |
| Ophthalmic Consultants Long Island /ID# 240211 | Oceanside | New York | 11572 | United States |
| Rochester Ophthalmological Group PC /ID# 240290 | Rochester | New York | 14618-2616 | United States |
| Glaucoma associates/consultants of the capital region /ID# 240195 | Slingerlands | New York | 12159 | United States |
| Montefiore Hospital /ID# 240324 | The Bronx | New York | 10467-2404 | United States |
| Asheville Eye Associates /ID# 240202 | Asheville | North Carolina | 28803 | United States |
| Charlotte Eye,Ear,Nose Throat /ID# 240339 | Belmont | North Carolina | 28012 | United States |
| Albemarle Clinical Trials LLC /ID# 240219 | Elizabeth City | North Carolina | 27909 | United States |
| Private Practice - Dr. James D. Branch /ID# 240188 | Winston-Salem | North Carolina | 27101 | United States |
| Bergstrom Eye Research LLC /ID# 240257 | Fargo | North Dakota | 58103 | United States |
| Oklahoma Eye Surgeons /ID# 250430 | Oklahoma City | Oklahoma | 73112 | United States |
| Legacy Devers Eye Institute /ID# 240210 | Portland | Oregon | 97210 | United States |
| Scott and Christie and Associates /ID# 240189 | Cranberry Township | Pennsylvania | 16066 | United States |
| Eye Specialty Group /ID# 240241 | Memphis | Tennessee | 38120 | United States |
| Vanderbilt Eye Institute /ID# 252659 | Nashville | Tennessee | 37232-0025 | United States |
| Advancing Vision Research /ID# 240288 | Smyrna | Tennessee | 37167 | United States |
| Keystone Research LTD /ID# 240185 | Austin | Texas | 78731-4203 | United States |
| Houston Eye Associates /ID# 240340 | Houston | Texas | 77025 | United States |
| DCT Shah Eye Research Institut /ID# 240306 | Mission | Texas | 78572 | United States |
| Plano Office /ID# 240243 | Plano | Texas | 75093 | United States |
| San Antonio Eye Center /ID# 240238 | San Antonio | Texas | 78215 | United States |
| Eye associates /ID# 240265 | San Antonio | Texas | 78229 | United States |
| Medical Center Ophthalmology Associates /ID# 240208 | San Antonio | Texas | 78240-1502 | United States |
| Emerson Clinical Research Institute. LLC /ID# 240274 | Falls Church | Virginia | 22046 | United States |
| Piedmont Eye Center /ID# 240187 | Lynchburg | Virginia | 24502 | United States |
| Vistar Eye Center /ID# 240198 | Roanoke | Virginia | 24011 | United States |
| Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247 | CABA | Buenos Aires | 1122 | Argentina |
| Clinica Privada de Ojos /ID# 240272 | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Hospital Universitario Austral /ID# 240331 | Pilar | Buenos Aires | 1629 | Argentina |
| Oftalmología Global /ID# 240244 | Rosario | Santa Fe Province | 2000 | Argentina |
| Oftar Mendoza /ID# 240308 | Mendoza | 1019 | Argentina |
| Universitair Ziekenhuis Leuven /ID# 240312 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Hospital de Olhos de Mato Grosso Do Sul /ID# 240276 | Campo Grande | Mato Grosso do Sul | 79002-075 | Brazil |
| Clinica De Oftalmologia Nova Campinas /ID# 240271 | Campinas | São Paulo | 13092-108 | Brazil |
| Hospital Oftalmologico Medicina dos Olhos /ID# 240277 | Osasco | São Paulo | 0601-8180 | Brazil |
| Hospital Sao Paulo /ID# 240278 | São Paulo | 04023-062 | Brazil |
| Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Ophthalmic Consultant Centres /ID# 240205 | Mississauga | Ontario | L4W 1W9 | Canada |
| Clinica de Oftalmologia Sandiego /ID# 240233 | Medellín | Antioquia | 050016 | Colombia |
| Fundacion Oftalmologica Nacional /ID# 240226 | Bogotá | Bogota D.C. | 110231 | Colombia |
| Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634 | Bucaramanga | Santander Department | 681004 | Colombia |
| Ocni klinika Pardubice /ID# 240347 | Pardubice | 530 02 | Czechia |
| Rigshospitalet Glostrup /ID# 240330 | Glostrup Municipality | Capital Region | 2600 | Denmark |
| Bostan Diagnostic Eye Center /ID# 240268 | Cairo | Egypt |
| Duplicate_Ain Shams University Hospital /ID# 240338 | Cairo | Egypt |
| CHU Bordeaux - Hopital Pellegrin /ID# 240316 | Bordeaux | New Aquitaine | 33076 | France |
| Centre Ophtalmologique Pôle Vision /ID# 240256 | Écully | Rhone | 69130 | France |
| Internationale Innovative Ophthalmochirurgie /ID# 240232 | Düsseldorf | North Rhine-Westphalia | 40212 | Germany |
| Universitaetsklinikum Magdeburg /ID# 240314 | Magdeburg | 39120 | Germany |
| The Chinese University of Hong Kong /ID# 240283 | Hong Kong | Hong Kong |
| Galilee Medical Center /ID# 251967 | Nahariya | Northern District | 2210001 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 240311 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus /ID# 240332 | Haifa | 3109601 | Israel |
| Bnai Zion Medical Center /ID# 240297 | Haifa | 3339419 | Israel |
| The Lady Davis Carmel Medical Center /ID# 240293 | Haifa | 34362 | Israel |
| AOU Policlinico G. Rodolico - San Marco /ID# 240305 | Catania | 95123 | Italy |
| ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217 | Chieti | 67100 | Italy |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310 | Perugia | 06156 | Italy |
| Azienda Ospedaliero Universitaria Pisana /ID# 240301 | Pisa | 56126 | Italy |
| Capital Eye Specialists /ID# 240259 | Wellington | 6011 | New Zealand |
| Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269 | Lima | LIMA 27 | Peru |
| Asian Eye Institute /ID# 240213 | Makati City | 1200 | Philippines |
| Asian Eye Institute /ID# 240214 | Makati City | 1200 | Philippines |
| Peregrine Eye and Laser Institute /ID# 240260 | Makati City | 1209 | Philippines |
| Oftalmika sp. z o.o. /ID# 240201 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-631 | Poland |
| Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258 | Lublin | Lublin Voivodeship | 20-079 | Poland |
| Duplicate_Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307 | Gdansk | Pomeranian Voivodeship | 80-809 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248 | Olsztyn | Warmian-Masurian Voivodeship | 10-424 | Poland |
| S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251 | Novosibirsk | Novosibirsk Oblast | 630071 | Russia |
| Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253 | Omsk | Omsk Oblast | 644024 | Russia |
| Singapore National Eye Centre /ID# 240224 | Singapore | 168251 | Singapore |
| Pretoria Eye Institute - Private Practice /ID# 240223 | Pretoria | Gauteng | 0083 | South Africa |
| Asan Medical Center /ID# 240286 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Samsung Medical Center /ID# 240335 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Duplicate_Seoul National University Hospital /ID# 240262 | Seoul | 03080 | South Korea |
| Hospital Universitario Reina Sofia /ID# 240322 | Córdoba | Cordoba | 14004 | Spain |
| Hospital Clinico San Carlos /ID# 240303 | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena /ID# 240325 | Seville | 41009 | Spain |
| Maharaj Nakorn Chiang Mai Hospital /ID# 240194 | Chiang Mai | 50200 | Thailand |
| Thammasat University Hospital /ID# 240231 | Pathum Thani | 12120 | Thailand |
| Eskisehir Osmangazi University Medical School /ID# 240225 | Eskişehir | 26480 | Turkey (Türkiye) |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296 | Istanbul | 34899 | Turkey (Türkiye) |
| Addenbrookes Hospital /ID# 240351 | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Duplicate_NHS Lothian /ID# 240318 | Edinburgh | EH3 9HE | United Kingdom |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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