Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Essendon, Australia, 3040
    • Essendon Eye Clinic /ID# 235433
  • Geelong, Australia, 3220
    • Geelong Eye Clinic /ID# 236118
  • Melbourne, Australia, 3058
    • Vision Eye Institute /ID# 236003
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Queensland Eye Institute /ID# 236074
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Eye Surgery Associates /ID# 235872
    • Fitzroy, Victoria, Australia, VIC3065
      • Melbourne Eye Specialists /ID# 234614
    • Glen Waverley, Victoria, Australia, 3150
      • Waverley Eye Clinic /ID# 234997
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lions Eye Institute /ID# 236832
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1V 1G5
      • Ophthalmology Clinic Bellevue /ID# 234631
• Denmark
  • Hovedstaden
    • Glostrup, Hovedstaden, Denmark, 2600
      • Rigshospitalet Glostrup /ID# 237709
• France
  • Angers, France, 49933
    • Chu Angers /Id# 237805
  • Avranches, France, 50300
    • Polyclinique de la Baie /ID# 235842
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hopital Pellegrin /ID# 237705
  • Montauban, France, 82000
    • Clinique Honore Cave - Pharmacie /ID# 235925
  • Nice, France, 06000
    • CHU de Nice - Hospital Pasteur 2 /ID# 235844
  • Strasbourg cedex, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 237837
  • Toulouse, France, 31000
    • Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966
  • Magdeburg, Germany, 39120
    • Universitaetsklinikum Magdeburg /ID# 237284
  • Nordrhein-Westfalen
    • Dusseldorf, Nordrhein-Westfalen, Germany, 40212
      • Internationale Innovative Ophthalmochirurgie /ID# 235263
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 237741
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center /ID# 236757
  • Nahariya, Israel, 2210001
    • Galilee Medical Center /ID# 235742
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 237698
  • Tel-Aviv
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 237211
• New Zealand
  • Wellington, New Zealand, 6011
    • Capital Eye Specialists /ID# 236111
  • Auckland
    • Remuera, Auckland, New Zealand, 1050
      • Auckland Eye Hospital /ID# 235253
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Southern Eye Specialists /ID# 236081
• Philippines
  • Makati City, Philippines, 1200
    • Asian Eye Institute /ID# 235092
  • Makati City, Philippines, 1209
    • Peregrine Eye and Laser Institute /ID# 236220
  • Makati City, Philippines, 1229
    • American Eye Center /ID# 235320
  • San Juan City, Philippines, 1502
    • Cardinal Santos Medical Center /ID# 235325
• Poland
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929
• Russian Federation
  • Omsk, Russian Federation, 644024
    • Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041
  • Samara, Russian Federation, 443099
    • Samara State Medical University /ID# 236997
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust /ID# 238315
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 237450
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust /ID# 237708
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust /ID# 234777
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust /ID# 237318
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129
  • Kent
    • Greater London, Kent, United Kingdom, DA14 6LT
      • Queen Mary's Hospital /ID# 234899
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 236806
  • Surrey
    • Carshalton, Surrey, United Kingdom, SM5 1AA
      • Epsom & St Helier University Hospital NHS Trust /ID# 236902
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group /ID# 234598
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Advanced Eye Research Institute /ID# 234947
    • Phoenix, Arizona, United States, 85050-4265
      • Arizona Glaucoma Specialists /ID# 235066
    • Prescott, Arizona, United States, 86301
      • M&M Eye Institute /ID# 235391
    • Sun City, Arizona, United States, 85351
      • Walman Eye Center /ID# 236054
  • California
    • Arcadia, California, United States, 91007
      • California Center for Clin Res /ID# 237412
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology /ID# 235995
    • Glendale, California, United States, 91203
      • Speciality Eye Care Medical Group /ID# 236001
    • Glendale, California, United States, 91204
      • Lugene Eye Institute /ID# 237042
    • Irvine, California, United States, 92604
      • Lakeside Vision Center /ID# 234971
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group Inc. /ID# 235999
    • Petaluma, California, United States, 94954-2387
      • North Bay Eye Associates Inc. /ID# 235429
    • San Francisco, California, United States, 94115
      • Pacific Eye Associates /ID# 235326
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates /ID# 235166
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Segal Drug Trials Inc. /ID# 235169
    • Fort Myers, Florida, United States, 33901-9311
      • Eye Associates of South West Florida /ID# 235424
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates Inc. /ID# 235021
    • Jacksonville, Florida, United States, 32209
      • University of Florida /ID# 236876
    • Ocala, Florida, United States, 34474
      • Ocala Eye PA /ID# 235431
    • Tamarac, Florida, United States, 33321
      • Dr. Andrew Gardner Logan, FL /ID# 236946
    • Tampa, Florida, United States, 33612
      • University of South Florida /ID# 237737
  • Georgia
    • Morrow, Georgia, United States, 30260-4180
      • Clayton Eye Clinical Research, LLC /ID# 236678
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Sabates Eye Centers /ID# 234868
  • Kentucky
    • Edgewood, Kentucky, United States, 41017-3415
      • Cincinnati Eye Institute- Edgewood /ID# 236714
    • Louisville, Kentucky, United States, 40206-1738
      • The Eye Care Institute /ID# 236690
  • Massachusetts
    • Reading, Massachusetts, United States, 01867
      • Advanced Glaucoma Specialists /ID# 234799
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Center /ID# 235791
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879
  • New Jersey
    • South Orange, New Jersey, United States, 07079-1855
      • Northern New Jersey Eye Institute PA /ID# 234944
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico /ID# 235115
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • Albemarle Clinical Trials LLC /ID# 235144
    • High Point, North Carolina, United States, 27262
      • Duplicate_Cornerstone Eye Care /ID# 235047
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bagan Strinden Vision /ID# 234898
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma Eye Surgeons /ID# 235848
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott and Christie and Associates /ID# 234594
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists /ID# 235129
    • Lancaster, Pennsylvania, United States, 17601-2644
      • Family Eye Group P.C. /ID# 236114
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital /ID# 236487
  • South Carolina
    • Florence, South Carolina, United States, 29501
      • Carolinas Centers for Sight,PC /ID# 237017
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Chattanooga Eye Institute /ID# 235250
  • Texas
    • Austin, Texas, United States, 78731
      • ATX Clinical Trials Inc. dba Keystone Research /ID# 235869
    • Bellaire, Texas, United States, 77401
      • Cross Eye Center /ID# 236116
    • Houston, Texas, United States, 77025
      • Houston Eye Associates /ID# 237883
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine - Baylor Medical Center /ID# 237148
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center /ID# 235632
    • San Antonio, Texas, United States, 78229
      • Eye associates /ID# 236501
    • San Antonio, Texas, United States, 78240-1502
      • Medical Center Ophthalmology Associates /ID# 235016
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute /ID# 235977
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center /ID# 234533
  • West Virginia
    • Morgantown, West Virginia, United States, 26501
      • West Virginia University Eye Institute /ID# 235174

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require IOP lowering treatment.
• In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
• In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.

Exclusion Criteria:

• History of previous laser trabeculoplasty
• History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
• Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
• Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye); Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).	Drug: Bimatoprost SR; Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.; Drug: Sham Bimatoprost SR; Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.; Procedure: Selective Laser Trabeculoplasty; SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.; Procedure: Sham Selective Laser Trabeculoplasty; Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Experimental: Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye); Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).	Drug: Bimatoprost SR; Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.; Drug: Sham Bimatoprost SR; Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.; Procedure: Selective Laser Trabeculoplasty; SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.; Procedure: Sham Selective Laser Trabeculoplasty; Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Experimental: Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye); Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.	Drug: Bimatoprost SR; Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.; Drug: Sham Bimatoprost SR; Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.; Procedure: Selective Laser Trabeculoplasty; SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.; Procedure: Sham Selective Laser Trabeculoplasty; Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Experimental: Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye); Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.	Drug: Bimatoprost SR; Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.; Drug: Sham Bimatoprost SR; Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.; Procedure: Selective Laser Trabeculoplasty; SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.; Procedure: Sham Selective Laser Trabeculoplasty; Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Intraocular Pressure at Week 4	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 4
Change From Baseline in Intraocular Pressure at Week 12	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 12
Change From Baseline in Intraocular Pressure at Week 24	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Initial Use of Non-study IOP-lowering Treatment	The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available.	From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
Change From Baseline in IOP at Weeks 8, 15, and 20	IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Weeks 8, 15, and 20

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2015
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimated): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 192024-093; 2015-002131-18 (EudraCT Number)

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