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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03891446




Registration number
NCT03891446
Ethics application status
Date submitted
25/03/2019
Date registered
27/03/2019

Titles & IDs
Public title
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Scientific title
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2018-003597-26
Secondary ID [2] 0 0
1698-302-007
Universal Trial Number (UTN)
Trial acronym
Maia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-Angle Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost SR
Other interventions - Standard of Care

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.

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.

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.

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.


Treatment: Drugs: Bimatoprost SR
Intraocular implant

Other interventions: Standard of Care
Standard of care treatment based on investigator's judgement.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of effect of Bimatoprost SR
Timepoint [1] 0 0
Approximately 24 months
Primary outcome [2] 0 0
Number of patients experiencing a treatment emergent adverse event
Timepoint [2] 0 0
Approximately 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/08/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Missouri
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New Mexico
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New York
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North Carolina
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North Dakota
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Mendoza
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Belgium
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Vlaams-Brabant
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Brazil
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Sao Paulo
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Brazil
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Campo Grande
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Canada
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Nova Scotia
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Canada
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Ontario
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Colombia
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Antioquia
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Colombia
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Distrito Capital De Bogota
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Colombia
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Santander
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Czechia
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Pardubice
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Denmark
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Hovedstaden
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Egypt
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Cairo
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France
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Gironde
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France
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Ecully
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Germany
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Nordrhein-Westfalen
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Germany
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Magdeburg
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Hong Kong
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Hong Kong
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Israel
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H_efa
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Israel
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HaTsafon
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Israel
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Tel-Aviv
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Italy
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Umbria
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Italy
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Catania
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Italy
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Chieti
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Italy
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Pisa
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Korea, Republic of
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Seoul
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Wellington
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Peru
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Lima
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Philippines
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Makati City
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Poland
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Pomorskie
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Poland
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Bydgoszcz
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Lublin
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Poland
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Olsztyn
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Singapore
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Singapore
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South Africa
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Gauteng
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Sevilla
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Thailand
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Chiang Mai
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Thailand
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Pathumthani
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Turkey
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Eskisehir
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Turkey
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Istanbul
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03891446