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Glaucoma, Open-AnglePhase 3NCT02507687

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

A Phase 3 study testing Bimatoprost SR and Selective Laser Trabeculoplasty in people with Glaucoma, Open-Angle and Ocular Hypertension, run by AbbVie at 95 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?
Bimatoprost SR and Selective Laser Trabeculoplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
95 sitesin 12 countries
Study dates
27 Aug 2015to 31 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

United States51 sites

  • Eye Associates of New Mexico /ID# 235115

    Albuquerque, New Mexico, 87109

  • California Center for Clin Res /ID# 237412

    Arcadia, California, 91007

  • ATX Clinical Trials Inc. dba Keystone Research /ID# 235869

    Austin, Texas, 78731

  • Cross Eye Center /ID# 236116

    Bellaire, Texas, 77401

  • Chattanooga Eye Institute /ID# 235250

    Chattanooga, Tennessee, 37411

  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879

    Chesterfield, Missouri, 63017

  • University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875

    Chicago, Illinois, 60612

  • Scott and Christie and Associates /ID# 234594

    Cranberry Township, Pennsylvania, 16066

  • Segal Drug Trials Inc. /ID# 235169

    Delray Beach, Florida, 33484

  • Trinity Research Group /ID# 234598

    Dothan, Alabama, 36301

  • Cincinnati Eye Institute- Edgewood /ID# 236714

    Edgewood, Kentucky, 41017-3415

  • Albemarle Clinical Trials LLC /ID# 235144

    Elizabeth City, North Carolina, 27909

  • Emerson Clinical Research Institute /ID# 235977

    Falls Church, Virginia, 22046

  • Bagan Strinden Vision /ID# 234898

    Fargo, North Dakota, 58103

  • Carolinas Centers for Sight,PC /ID# 237017

    Florence, South Carolina, 29501

  • Eye Associates of South West Florida /ID# 235424

    Fort Myers, Florida, 33901-9311

  • Fraser Eye Center /ID# 235791

    Fraser, Michigan, 48026

  • Orange County Ophthalmology /ID# 235995

    Garden Grove, California, 92843

  • Arizona Advanced Eye Research Institute /ID# 234947

    Glendale, Arizona, 85306

  • Speciality Eye Care Medical Group /ID# 236001

    Glendale, California, 91203

  • Lugene Eye Institute /ID# 237042

    Glendale, California, 91204

  • Duplicate_Cornerstone Eye Care /ID# 235047

    High Point, North Carolina, 27262

  • Houston Eye Associates /ID# 237883

    Houston, Texas, 77025

  • Baylor College of Medicine - Baylor Medical Center /ID# 237148

    Houston, Texas, 77030-3411

  • Lakeside Vision Center /ID# 234971

    Irvine, California, 92604

  • Levenson Eye Associates Inc. /ID# 235021

    Jacksonville, Florida, 32204

  • University of Florida /ID# 236876

    Jacksonville, Florida, 32209

  • Eye Care Specialists /ID# 235129

    Kingston, Pennsylvania, 18704

  • Family Eye Group P.C. /ID# 236114

    Lancaster, Pennsylvania, 17601-2644

  • Sabates Eye Centers /ID# 234868

    Leawood, Kansas, 66211

  • The Eye Care Institute /ID# 236690

    Louisville, Kentucky, 40206-1738

  • Piedmont Eye Center /ID# 234533

    Lynchburg, Virginia, 24502

  • West Virginia University Eye Institute /ID# 235174

    Morgantown, West Virginia, 26501

  • Clayton Eye Clinical Research, LLC /ID# 236678

    Morrow, Georgia, 30260-4180

  • Ocala Eye PA /ID# 235431

    Ocala, Florida, 34474

  • Oklahoma Eye Surgeons /ID# 235848

    Oklahoma City, Oklahoma, 73112

  • California Eye Specialists Medical Group Inc. /ID# 235999

    Pasadena, California, 91107

  • North Bay Eye Associates Inc. /ID# 235429

    Petaluma, California, 94954-2387

  • Wills Eye Hospital /ID# 236487

    Philadelphia, Pennsylvania, 19107

  • Arizona Glaucoma Specialists /ID# 235066

    Phoenix, Arizona, 85050-4265

  • M&M Eye Institute /ID# 235391

    Prescott, Arizona, 86301

  • Advanced Glaucoma Specialists /ID# 234799

    Reading, Massachusetts, 01867

  • San Antonio Eye Center /ID# 235632

    San Antonio, Texas, 78215

  • Eye associates /ID# 236501

    San Antonio, Texas, 78229

  • Medical Center Ophthalmology Associates /ID# 235016

    San Antonio, Texas, 78240-1502

  • Pacific Eye Associates /ID# 235326

    San Francisco, California, 94115

  • Northern New Jersey Eye Institute PA /ID# 234944

    South Orange, New Jersey, 07079-1855

  • Walman Eye Center /ID# 236054

    Sun City, Arizona, 85351

  • Dr. Andrew Gardner Logan, FL /ID# 236946

    Tamarac, Florida, 33321

  • University of South Florida /ID# 237737

    Tampa, Florida, 33612

  • Wolstan & Goldberg Eye Associates /ID# 235166

    Torrance, California, 90505

Other trials in United States

United Kingdom9 sites

  • Cambridge University Hospitals NHS Foundation Trust /ID# 238315

    Cambridge, CB2 0QQ

  • Epsom & St Helier University Hospital NHS Trust /ID# 236902

    Carshalton, Surrey, SM5 1AA

  • University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129

    Derby, Derbyshire, DE22 3NE

  • NHS Lothian /ID# 237450

    Edinburgh, EH3 9HE

  • Queen Mary's Hospital /ID# 234899

    Greater London, Kent, DA14 6LT

  • Guys and St Thomas NHS Foundation Trust /ID# 236806

    London, London, City of, SE1 9RT

  • Moorfields Eye Hospital NHS Foundation Trust /ID# 237708

    London, EC1V 2PD

  • Imperial College Healthcare NHS Trust /ID# 234777

    London, W2 1NY

  • Manchester University NHS Foundation Trust /ID# 237318

    Manchester, M13 9WL

Other trials in United Kingdom

Australia8 sites

  • Eye Surgery Associates /ID# 235872

    East Melbourne, Victoria, 3002

  • Essendon Eye Clinic /ID# 235433

    Essendon, 3040

  • Melbourne Eye Specialists /ID# 234614

    Fitzroy, Victoria, VIC3065

  • Geelong Eye Clinic /ID# 236118

    Geelong, 3220

  • Waverley Eye Clinic /ID# 234997

    Glen Waverley, Victoria, 3150

  • Vision Eye Institute /ID# 236003

    Melbourne, 3058

  • The Lions Eye Institute /ID# 236832

    Nedlands, Western Australia, 6009

  • Queensland Eye Institute /ID# 236074

    South Brisbane, Queensland, 4101

Other trials in Australia

France7 sites

  • Chu Angers /Id# 237805

    Angers, 49933

  • Polyclinique de la Baie /ID# 235842

    Avranches, 50300

  • CHU Bordeaux - Hopital Pellegrin /ID# 237705

    Bordeaux, 33000

  • Clinique Honore Cave - Pharmacie /ID# 235925

    Montauban, 82000

  • CHU de Nice - Hospital Pasteur 2 /ID# 235844

    Nice, 06000

  • CHU Strasbourg - Hopital Civil /ID# 237837

    Strasbourg, 67091

  • Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841

    Toulouse, 31000

Other trials in France

Israel5 sites

  • Rambam Health Care Campus /ID# 237741

    Haifa, 3109601

  • The Lady Davis Carmel Medical Center /ID# 236757

    Haifa, 34362

  • Galilee Medical Center /ID# 235742

    Nahariya, 2210001

  • Rabin Medical Center /ID# 237698

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center /ID# 237211

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Philippines4 sites

  • Asian Eye Institute /ID# 235092

    Makati City, 1200

  • Peregrine Eye and Laser Institute /ID# 236220

    Makati City, 1209

  • American Eye Center /ID# 235320

    Makati City, 1229

  • Cardinal Santos Medical Center /ID# 235325

    San Juan City, 1502

Other trials in Philippines

Germany3 sites

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966

    Berlin, 13353

  • Internationale Innovative Ophthalmochirurgie /ID# 235263

    Düsseldorf, North Rhine-Westphalia, 40212

  • Universitaetsklinikum Magdeburg /ID# 237284

    Magdeburg, 39120

Other trials in Germany

New Zealand3 sites

  • Southern Eye Specialists /ID# 236081

    Christchurch, Canterbury, 8013

  • Auckland Eye Hospital /ID# 235253

    Remuera, Auckland, 1050

  • Capital Eye Specialists /ID# 236111

    Wellington, 6011

Other trials in New Zealand

Russia2 sites

  • Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041

    Omsk, 644024

  • Samara State Medical University /ID# 236997

    Samara, 443099

Other trials in Russia

Canada1 site

  • Ophthalmology Clinic Bellevue /ID# 234631

    Montreal, Quebec, H1V 1G5

Other trials in Canada

Denmark1 site

  • Rigshospitalet Glostrup /ID# 237709

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

Poland1 site

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929

    Olsztyn, 10-424

Other trials in Poland

About this study

Official title: 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).

Being tested
Bimatoprost SR, Sham Bimatoprost SR, Selective Laser Trabeculoplasty, Sham Selective Laser Trabeculoplasty
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimatoprost SRDrug

    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.

  • Sham Bimatoprost SRDrug

    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.

  • Selective Laser TrabeculoplastyProcedure or surgery

    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.

  • Sham Selective Laser TrabeculoplastyProcedure or surgery

    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.

Study groups in NCT02507687
Study groupRoleWhat they receive
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)ExperimentalParticipants 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).
Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)ExperimentalParticipants 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).
Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)ExperimentalParticipants 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.
Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)ExperimentalParticipants 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.
Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 4

  2. 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.

    Measured: Baseline and Week 12

  3. 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.

    Measured: Baseline and Week 24

Secondary outcomes (3)

  1. 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.

    Measured: From first administration of study treatment to the end of study; overall median follow-up time of 728 days.

  2. 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.

    Measured: 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

  3. 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.

    Measured: Baseline and Weeks 8, 15, and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2015 (estimated)
  2. Study start27 Aug 2015
  3. Primary completion24 Nov 2021
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02507687
Sponsor's protocol ID
192024-093
Other IDs
2015-002131-18, 2015
Status last verified
Apr 2024
First submitted
22 Jul 2015
Last updated
10 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Kolko M, Tatham AJ, Lim KS, Wells AP, Shiu M, Uy HS, Sarkisian SR Jr, Ho Q, Jiao J, Kim K, Goodkin ML, Bejanian M, Robinson MR, Paauw JD; ATHENA STUDY GROUP. Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 microg and Selective Laser Trabeculoplasty. Am J Ophthalmol. 2025 Apr;272:19-37. doi: 10.1016/j.ajo.2024.12.026. Epub 2025 Jan 10.

    PubMed 39800203

  • 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.

    PubMed 35943114

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost SR and Selective Laser Trabeculoplasty in people with Glaucoma, Open-Angle and Ocular Hypertension, run by AbbVie at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, United Kingdom, Australia, France, Israel and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Intraocular Pressure at Week 4 (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507687, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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