Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Ocular Hypertension Clinical Trial

— Maia  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03891446
• Other study ID #: 1698-302-007
• Secondary ID: 2018-003597-2620
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 27, 2019
• Est. completion date: August 7, 2026

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 7, 2026
• Est. primary completion date: August 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost SR
Intraocular implant

Other:
• Standard of Care
Standard of care treatment based on investigator's judgement.

Locations

Country	Name	City	State
Argentina	Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247	Caba	Buenos Aires
Argentina	Clinica Privada de Ojos /ID# 240272	Mar del Plata	Buenos Aires
Argentina	Oftar Mendoza /ID# 240308	Mendoza
Argentina	Hospital Universitario Austral /ID# 240331	Pilar	Buenos Aires
Argentina	Oftalmología Global /ID# 240244	Rosario	Santa Fe
Belgium	Universitair Ziekenhuis Leuven /ID# 240312	Leuven	Vlaams-Brabant
Brazil	Clinica De Oftalmologia Nova Campinas /ID# 240271	Campinas	Sao Paulo
Brazil	Hospital de Olhos de Mato Grosso Do Sul /ID# 240276	Campo Grande
Brazil	Hospital Oftalmologico Medicina dos Olhos /ID# 240277	Osasco	Sao Paulo
Brazil	Hospital Sao Paulo /ID# 240278	Sao Paulo
Canada	Dalhousie University /ID# 240336	Halifax	Nova Scotia
Canada	Ophthalmic Consultant Centres /ID# 240205	Mississauga	Ontario
Colombia	Fundacion Oftalmologica Nacional /ID# 240226	Bogota	Distrito Capital De Bogota
Colombia	Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634	Bucaramanga	Santander
Colombia	Clinica de Oftalmologia Sandiego /ID# 240233	Medellin	Antioquia
Czechia	Ocni klinika Pardubice /ID# 240347	Pardubice
Denmark	Rigshospitalet Glostrup /ID# 240330	Glostrup	Hovedstaden
Egypt	Ain Shams University Hospital /ID# 240338	Cairo
Egypt	Bostan Diagnostic Eye Center /ID# 240268	Cairo
France	CHU Bordeaux - Hopital Pellegrin /ID# 240316	Bordeaux CEDEX	Gironde
France	Centre Ophtalmologique Pôle Vision /ID# 240256	Ecully
Germany	Internationale Innovative Ophthalmochirurgie /ID# 240232	Dusseldorf	Nordrhein-Westfalen
Germany	Universitaetsklinikum Magdeburg /ID# 240314	Magdeburg
Hong Kong	The Chinese University of Hong Kong /ID# 240283	Hong Kong
Israel	Bnai Zion Medical Center /ID# 240297	Haifa	H_efa
Israel	Rambam Health Care Campus /ID# 240332	Haifa	H_efa
Israel	The Lady Davis Carmel Medical Center /ID# 240293	Haifa	H_efa
Israel	Galilee Medical Center /ID# 251967	Naharia	HaTsafon
Israel	Tel Aviv Sourasky Medical Center /ID# 240311	Tel Aviv	Tel-Aviv
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305	Catania
Italy	Azienda Sanitaria Locale (ASL) Chieti /ID# 240217	Chieti
Italy	Azienda Ospedaliera di Perugia /ID# 240310	Perugia	Umbria
Italy	Azienda Ospedaliero Universitaria Pisana /ID# 240301	Pisa
Korea, Republic of	Asan Medical Center /ID# 240286	Seoul
Korea, Republic of	Samsung Medical Center /ID# 240335	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 240262	Seoul
New Zealand	Capital Eye Specialists /ID# 240259	Wellington
Peru	Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269	Lima
Philippines	Asian Eye Institute /ID# 240213	Makati City
Philippines	Asian Eye Institute /ID# 240214	Makati City
Philippines	Peregrine Eye and Laser Institute /ID# 240260	Makati City
Poland	OFTALMIKA Sp. z o.o. /ID# 240201	Bydgoszcz
Poland	Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307	Gdansk	Pomorskie
Poland	Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258	Lublin
Poland	Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248	Olsztyn
Russian Federation	S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251	Novosibirsk
Russian Federation	Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253	Omsk
Singapore	Singapore National Eye Centre /ID# 240224	Singapore
South Africa	Pretoria Eye Institute - Private Practice /ID# 240223	Pretoria	Gauteng
Spain	Hospital Universitario Reina Sofia /ID# 240322	Cordoba
Spain	Hospital Clinico Universitario San Carlos /ID# 240303	Madrid
Spain	Hospital Universitario Virgen Macarena /ID# 240325	Sevilla
Thailand	Maharaj Nakorn Chiang Mai Hospital /ID# 240194	Chiang Mai
Thailand	Thammasat University Hospital /ID# 240231	Pathumthani
Turkey	Eskisehir Osmangazi University Medical School /ID# 240225	Eskisehir
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296	Istanbul
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 240351	Cambridge
United Kingdom	Duplicate_NHS Lothian /ID# 240318	Edinburgh
United States	Eye Associates of New Mexico /ID# 240216	Albuquerque	New Mexico
United States	Asheville Eye Associates /ID# 240202	Asheville	North Carolina
United States	Emory University /ID# 240328	Atlanta	Georgia
United States	Keystone Research LTD /ID# 240185	Austin	Texas
United States	Chicago Eye Specialists /ID# 240270	Bedford Park	Illinois
United States	Charlotte Eye,Ear,Nose Throat /ID# 240339	Belmont	North Carolina
United States	Montefiore Hospital /ID# 240324	Bronx	New York
United States	Arizona Eye Center /ID# 240239	Chandler	Arizona
United States	Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402	Chesterfield	Missouri
United States	University of Illinois at Chicago /ID# 250981	Chicago	Illinois
United States	Colorado Eye Institute /ID# 248910	Colorado Springs	Colorado
United States	Specialty Retina Center /ID# 240254	Coral Springs	Florida
United States	Scott and Christie and Associates /ID# 240189	Cranberry Township	Pennsylvania
United States	Nature Coast Clinical Research - Crystal River /ID# 240334	Crystal River	Florida
United States	Angeles Eye Institute /ID# 250397	Culver City	California
United States	Bruce Segal, MD /ID# 240292	Delray Beach	Florida
United States	Trinity Research Group /ID# 240190	Dothan	Alabama
United States	Eye Associates of North Jersey /ID# 250445	Dover	New Jersey
United States	Albemarle Clinical Trials LLC /ID# 240219	Elizabeth City	North Carolina
United States	Kovach Eye Institute /ID# 250442	Elmhurst	Illinois
United States	Emerson Clinical Research Institute. LLC /ID# 240274	Falls Church	Virginia
United States	Bergstrom Eye Research LLC /ID# 240257	Fargo	North Dakota
United States	Eye Associates of Fort Meyers /ID# 240218	Fort Myers	Florida
United States	Fraser Eye Center /ID# 240245	Fraser	Michigan
United States	Houston Eye Associates /ID# 240340	Houston	Texas
United States	IN Univ School of Medicine /ID# 240294	Indianapolis	Indiana
United States	Lakeside Vision Center /ID# 240204	Irvine	California
United States	Levenson Eye Associates Inc. /ID# 240209	Jacksonville	Florida
United States	Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196	La Jolla	California
United States	Glaucoma Care Center /ID# 250978	Livingston	New Jersey
United States	The Eye Care Institute /ID# 240289	Louisville	Kentucky
United States	Piedmont Eye Center /ID# 240187	Lynchburg	Virginia
United States	Eye Specialty Group /ID# 240241	Memphis	Tennessee
United States	MedEye Associates /ID# 240333	Miami	Florida
United States	DCT Shah Eye Research Institut /ID# 240306	Mission	Texas
United States	Vanderbilt Eye Institute /ID# 252659	Nashville	Tennessee
United States	Tulane University /ID# 240327	New Orleans	Louisiana
United States	Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181	Newark	New Jersey
United States	The Eye Research Foundation /ID# 240186	Newport Beach	California
United States	Ophthalmic Consultants Long Island /ID# 240211	Oceanside	New York
United States	Oklahoma Eye Surgeons /ID# 250430	Oklahoma City	Oklahoma
United States	North Bay Eye Associates Inc. /ID# 248912	Petaluma	California
United States	Arizona Glaucoma Specialists /ID# 240212	Phoenix	Arizona
United States	Plano Office /ID# 240243	Plano	Texas
United States	Legacy Devers Eye Institute /ID# 240210	Portland	Oregon
United States	M&M Eye Institute /ID# 240236	Prescott	Arizona
United States	Martel Eye Medical Group /ID# 240291	Rancho Cordova	California
United States	The Clinical Trials Network (CTNx) /ID# 240284	Redding	California
United States	Vistar Eye Center /ID# 240198	Roanoke	Virginia
United States	Rochester Ophthalmological Group PC /ID# 240290	Rochester	New York
United States	Coastal Research Associates /ID# 240192	Roswell	Georgia
United States	Sacramento Eye Consultants /ID# 240263	Sacramento	California
United States	Tekwani Vision Center /ID# 240220	Saint Louis	Missouri
United States	Eye associates /ID# 240265	San Antonio	Texas
United States	Medical Center Ophthalmology Associates /ID# 240208	San Antonio	Texas
United States	San Antonio Eye Center /ID# 240238	San Antonio	Texas
United States	Pacific Eye Associates /ID# 240234	San Francisco	California
United States	Glaucoma associates/consultants of the capital region /ID# 240195	Slingerlands	New York
United States	Advancing Vision Research /ID# 240288	Smyrna	Tennessee
United States	Walman Eye Center /ID# 240255	Sun City	Arizona
United States	Logan Ophthalmic Research Inc. /ID# 240280	Tamarac	Florida
United States	International Research Center /ID# 240346	Tampa	Florida
United States	University of South Florida /ID# 250980	Tampa	Florida
United States	Wolstan & Goldberg Eye Associates /ID# 240221	Torrance	California
United States	Clinical Eye Research of Boston LLC /ID# 240203	Winchester	Massachusetts
United States	James D Branch MD /ID# 240188	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Colombia,  Czechia,  Denmark,  Egypt,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  New Zealand,  Peru,  Philippines,  Poland,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of effect of Bimatoprost SR	Retreatment or rescue administered for IOP lowering, determined by the investigator.	Approximately 24 months
Primary	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

External Links

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